This research aimed to analyze and contrast the antibiotic prescription trends that occur in dentistry offices. for the management of dental infections. To fill out the data, each dentist enrolled in the study was asked to record antibiotics prescribed for 6 -8 months and then the records were collected. Recorded dental prescriptions for antibiotics served as the study’s source population, and the list of patients who brought their prescription cards to the dental office within the allotted window of time (January 1 to December 31, 2015) served as its sampling frame. Using a statistical technique, After selecting patient record cards that included at least one antibiotic during the course of the investigation, the appropriate size of the sample was determined. The study employed a retrospective analysis of prescribing data from 10 private dental clinics, encompassing a sample of dental infection cases and corresponding antibiotic prescriptions. Data on the type and frequency of antibiotics and patient medical history and age were collected and analyzed. Descriptive statistics and statistical tests were used to examine the relationships between antibiotic prescribing patterns and patient factors. The results revealed significant associations between medical history, patient age, and antibiotic prescribing patterns. The findings highlight the need for personalized prescribing approaches based on patient factors, standardized clinical processes, and cost-effective antibiotic choices. Improving compliance with clinical guidelines can help optimize antibiotic use and enhance patient outcomes in dental practice.
{"title":"Comparative Analysis of Antibiotic Prescribing Patterns for Dental Infections: A Retrospective Study in a Dental Clinic","authors":"Hiroj Bagde, Ashwini Dhopte","doi":"10.25258/ijpqa.14.3.42","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.42","url":null,"abstract":"This research aimed to analyze and contrast the antibiotic prescription trends that occur in dentistry offices. for the management of dental infections. To fill out the data, each dentist enrolled in the study was asked to record antibiotics prescribed for 6 -8 months and then the records were collected. Recorded dental prescriptions for antibiotics served as the study’s source population, and the list of patients who brought their prescription cards to the dental office within the allotted window of time (January 1 to December 31, 2015) served as its sampling frame. Using a statistical technique, After selecting patient record cards that included at least one antibiotic during the course of the investigation, the appropriate size of the sample was determined. The study employed a retrospective analysis of prescribing data from 10 private dental clinics, encompassing a sample of dental infection cases and corresponding antibiotic prescriptions. Data on the type and frequency of antibiotics and patient medical history and age were collected and analyzed. Descriptive statistics and statistical tests were used to examine the relationships between antibiotic prescribing patterns and patient factors. The results revealed significant associations between medical history, patient age, and antibiotic prescribing patterns. The findings highlight the need for personalized prescribing approaches based on patient factors, standardized clinical processes, and cost-effective antibiotic choices. Improving compliance with clinical guidelines can help optimize antibiotic use and enhance patient outcomes in dental practice.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"19 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867699","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Amit Chawla, Lalchand Devhare, G. Dharmamoorthy, Ritika ., Sachin Tyagi
The development of novel antitumor agents is paramount in the fight against drug resistance and its associated cardiotoxicity. The present study carried out a thorough anticancer evaluation of N- (4-oxo-2-(4-((5-aryl-1,3,4 thiadiazole-2yl) amino) phenyl thiazolidine-3-yl) benzamide (TH08) in Ehrlich ascites carcinoma (EAC) in Swiss albino mice. Our assessment included the measurement of tumor weight, the duration of survival for mice with tumors, and tumor cell growth inhibition. Additionally, we analyzed hematological parameters, like white and red blood cells and hemoglobin levels. The results we obtained clearly demonstrate that TH08 is a potent anticancer agent that exerts a positive effect on EAC cells. To determine TH08's effectiveness, We compared our findings to those achieved by using the standard medication, bleomycin. Our findings provide compelling evidence that TH08 has significant potential as a novel antitumor agent.
{"title":"Synthesis and In-vivo Anticancer Evaluation of N-(4-oxo-2- (4-((5-aryl-1,3,4 thiadiazole-2yl) amino) Phenyl thiazolidine-3-yl) Benzamide derivative","authors":"Amit Chawla, Lalchand Devhare, G. Dharmamoorthy, Ritika ., Sachin Tyagi","doi":"10.25258/ijpqa.14.3.02","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.02","url":null,"abstract":"The development of novel antitumor agents is paramount in the fight against drug resistance and its associated cardiotoxicity. The present study carried out a thorough anticancer evaluation of N- (4-oxo-2-(4-((5-aryl-1,3,4 thiadiazole-2yl) amino) phenyl thiazolidine-3-yl) benzamide (TH08) in Ehrlich ascites carcinoma (EAC) in Swiss albino mice. Our assessment included the measurement of tumor weight, the duration of survival for mice with tumors, and tumor cell growth inhibition. Additionally, we analyzed hematological parameters, like white and red blood cells and hemoglobin levels. The results we obtained clearly demonstrate that TH08 is a potent anticancer agent that exerts a positive effect on EAC cells. To determine TH08's effectiveness, We compared our findings to those achieved by using the standard medication, bleomycin. Our findings provide compelling evidence that TH08 has significant potential as a novel antitumor agent.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Oral cancer is the sixth most commonly diagnosed cancer in the world. Still, awareness of this disease among undergraduate health profession university students is insufficient. Many students lack an understanding of risk factors and early signs of oral cancer. Therefore rises a need to increase awareness of oral cancer among health profession graduates so that they may be trained to recognize, diagnose, and properly manage this potentially deadly disease. Method: This study aimed to assess the current awareness and knowledge in oral cancer, focusing on prevention, early detection and adequate referral amongst undergraduate students studying a healthcare profession at Al-Quds University. This was a qualitative survey conducted among 64 senior students at various health profession undergraduate programs. The survey was distributed online and included questions about prevention, early detection, adequate referral, and overall confidence. Results: The results of the survey indicate that dental students had a higher confidence level in the subject of oral cancer than non-dental students, with the highest levels of confidence in prevention and lower levels of confidence in adequate referral. Additionally, the results suggest that a larger proportion of non-dental students showed lower confidence in the survey, and a higher proportion of dental students showed higher confidence. Conclusion: In conclusion, this survey revealed that dental students had a higher level of confidence in the areas of prevention, early detection, and overall confidence than non-dental students. Additionally, more emphasis on these aspects is recommended for all health profession students in necessary.
{"title":"Confidence in Oral Cancer Awareness among Undergraduate Health Profession University Students at Al-Quds University","authors":"Nour Qawasmeh, Mohammad Assaf, Deniz Noyun","doi":"10.25258/ijpqa.14.3.44","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.44","url":null,"abstract":"Background: Oral cancer is the sixth most commonly diagnosed cancer in the world. Still, awareness of this disease among undergraduate health profession university students is insufficient. Many students lack an understanding of risk factors and early signs of oral cancer. Therefore rises a need to increase awareness of oral cancer among health profession graduates so that they may be trained to recognize, diagnose, and properly manage this potentially deadly disease. Method: This study aimed to assess the current awareness and knowledge in oral cancer, focusing on prevention, early detection and adequate referral amongst undergraduate students studying a healthcare profession at Al-Quds University. This was a qualitative survey conducted among 64 senior students at various health profession undergraduate programs. The survey was distributed online and included questions about prevention, early detection, adequate referral, and overall confidence. Results: The results of the survey indicate that dental students had a higher confidence level in the subject of oral cancer than non-dental students, with the highest levels of confidence in prevention and lower levels of confidence in adequate referral. Additionally, the results suggest that a larger proportion of non-dental students showed lower confidence in the survey, and a higher proportion of dental students showed higher confidence. Conclusion: In conclusion, this survey revealed that dental students had a higher level of confidence in the areas of prevention, early detection, and overall confidence than non-dental students. Additionally, more emphasis on these aspects is recommended for all health profession students in necessary.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"36 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In hyperlipidemic wistar albino rat models produced by triton and diet, the efficacy of polyherbal formulations containing four different plants was assessed. Rats exposed to Triton WR 1339 had their blood cholesterol and triglyceride levels raised. However, this was reversed when the rats were given syrup or a comparable formulation. Both formulations better lipid outlines in rats with high-fat diet-induced hyperlipidemia. Effects were marginally better with the usual medication Atrovastatin. Liver sinusoidal capillary dilations, cytoplasmic fatty infiltration, and granular degeneration were considerably reduced in polyherbal formulation-treated group II animals related with other groups. As per results, polyherbal formulations in dyslipidaemic circumstances reduce lipid levels by blocking the production of cholesterol and reducing lipid utilization.
{"title":"Hypolipidemic Activity of a Polyherbal Formulation in Triton WR-1339 and High Fat Diet-induced Hyperlipidemic Rats","authors":"Vishal Lad, Sufiyan Ahmad","doi":"10.25258/ijpqa.14.3.39","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.39","url":null,"abstract":"In hyperlipidemic wistar albino rat models produced by triton and diet, the efficacy of polyherbal formulations containing four different plants was assessed. Rats exposed to Triton WR 1339 had their blood cholesterol and triglyceride levels raised. However, this was reversed when the rats were given syrup or a comparable formulation. Both formulations better lipid outlines in rats with high-fat diet-induced hyperlipidemia. Effects were marginally better with the usual medication Atrovastatin. Liver sinusoidal capillary dilations, cytoplasmic fatty infiltration, and granular degeneration were considerably reduced in polyherbal formulation-treated group II animals related with other groups. As per results, polyherbal formulations in dyslipidaemic circumstances reduce lipid levels by blocking the production of cholesterol and reducing lipid utilization.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867469","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
After being prevailing in Central and West Africa throughout the 1970s, sporadic cases of monkeypox sickness have surfaced in recent years. On the other hand, the monkey pox outbreak in the United States made headlines and garnered international attention in 2003. In 2022, the virus has caused a catastrophic pandemic, with over 50 nations being affected. There were 183 new cases of monkeypox recorded to WHO in April 2023, representing a 0.2% rise in overall cases, and 14 new deaths from the disease. Monkey pox shares the poxviridae family with the smallpox virus. One explanation for the rise of monkeypox in people is the discontinuation of smallpox immunizations. The zoonotic infectious illness is distinguished by a pustular rash resembling smallpox and systemic infection with severity ranging from mild to severe. Though the condition is self-limiting, the consequences it causes can be deadly. The illness has no particular therapy, however, it can be treated using antivirals that are effective against smallpox. Vaccines for smallpox have also been shown to be effective. The current article addresses the signs and symptoms of monkeypox sickness and the transmission pathways and treatment choices.
{"title":"Resurgence of Human Monkey Pox: A Review","authors":"Shilpa Raut, Kajal Baviskar, Komal Mahajan, Shamal Dawange, Mayur Bidkar, Anjali Bedse, Harshal Tare","doi":"10.25258/ijpqa.14.3.58","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.58","url":null,"abstract":"After being prevailing in Central and West Africa throughout the 1970s, sporadic cases of monkeypox sickness have surfaced in recent years. On the other hand, the monkey pox outbreak in the United States made headlines and garnered international attention in 2003. In 2022, the virus has caused a catastrophic pandemic, with over 50 nations being affected. There were 183 new cases of monkeypox recorded to WHO in April 2023, representing a 0.2% rise in overall cases, and 14 new deaths from the disease. Monkey pox shares the poxviridae family with the smallpox virus. One explanation for the rise of monkeypox in people is the discontinuation of smallpox immunizations. The zoonotic infectious illness is distinguished by a pustular rash resembling smallpox and systemic infection with severity ranging from mild to severe. Though the condition is self-limiting, the consequences it causes can be deadly. The illness has no particular therapy, however, it can be treated using antivirals that are effective against smallpox. Vaccines for smallpox have also been shown to be effective. The current article addresses the signs and symptoms of monkeypox sickness and the transmission pathways and treatment choices.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"26 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rheumatoid arthritis (RA) is a persistent condition resulting in an inflammatory response abide by the pathological mechanism of autoimmunity that causes the cartilage, bone, and joint tissues to deteriorate, lowering one’s quality of life in general. Several studies have suggested a significant association between oxidative stress caused by leukocyte-mediated inflammatory responses and the conversion of a substantial amount of oxygen into diverse free radicals, resulting in oxidative harm, including the chronic nature of rheumatoid arthritis. The utilization of DMARDs which are known as biologic and conventional disease-modifying antirheumatic drugs, has exhibited encouraging results. However, it is crucial to prioritize the discovery of novel and efficacious medications for rheumatoid arthritis in order to address the constraints associated with current therapeutic approaches. Selegiline, a synthetic drug primarily employed to manage Parkinson’s disease, predominantly interferes with the MAO-B enzyme, also known as monoamine oxidase. Additionally, it has been demonstrated to possess free radical-neutralizing properties. The goal of this study is to assess the effectiveness of selegiline in reducing oxidative stress indicators in peripheral blood mononuclear lymphocyte cells isolated from individuals diagnosed with RA. Peripheral blood was collected from 20 RA patients in accordance with the American College of Rheumatology standard. Lymphocytes were isolated following incubation with 1.5 μg/mL phorbol myristate acetate (PMA) and treatment with different concentrations (50–200 μg/mL) of selegiline. This study reveals that selegiline in concentrations of 150 and 200 μg/mL was effective enough to alleviate oxidative stress by scavenging free radicals and improving the level of natural defensive enzymes playing as antioxidants. Therefore, it can be concluded that the MAO-B inhibitor selegiline has potential as a non-toxic repurposed medicine for curtailing the pathological effects of oxidative overload during RA, unlocking the opportunity for further investigation into the impact on other inflammatory cells, such as neutrophils.
{"title":"The Effect of Selegiline on Reducing Oxidative Stress in Polymorphonuclear Blood Cells (Lymphocytes) Isolated from Patients with Rheumatoid Arthritis","authors":"Purbajit Chetia, Abdul B Ahmed","doi":"10.25258/ijpqa.14.3.06","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.06","url":null,"abstract":"Rheumatoid arthritis (RA) is a persistent condition resulting in an inflammatory response abide by the pathological mechanism of autoimmunity that causes the cartilage, bone, and joint tissues to deteriorate, lowering one’s quality of life in general. Several studies have suggested a significant association between oxidative stress caused by leukocyte-mediated inflammatory responses and the conversion of a substantial amount of oxygen into diverse free radicals, resulting in oxidative harm, including the chronic nature of rheumatoid arthritis. The utilization of DMARDs which are known as biologic and conventional disease-modifying antirheumatic drugs, has exhibited encouraging results. However, it is crucial to prioritize the discovery of novel and efficacious medications for rheumatoid arthritis in order to address the constraints associated with current therapeutic approaches. Selegiline, a synthetic drug primarily employed to manage Parkinson’s disease, predominantly interferes with the MAO-B enzyme, also known as monoamine oxidase. Additionally, it has been demonstrated to possess free radical-neutralizing properties. The goal of this study is to assess the effectiveness of selegiline in reducing oxidative stress indicators in peripheral blood mononuclear lymphocyte cells isolated from individuals diagnosed with RA. Peripheral blood was collected from 20 RA patients in accordance with the American College of Rheumatology standard. Lymphocytes were isolated following incubation with 1.5 μg/mL phorbol myristate acetate (PMA) and treatment with different concentrations (50–200 μg/mL) of selegiline. This study reveals that selegiline in concentrations of 150 and 200 μg/mL was effective enough to alleviate oxidative stress by scavenging free radicals and improving the level of natural defensive enzymes playing as antioxidants. Therefore, it can be concluded that the MAO-B inhibitor selegiline has potential as a non-toxic repurposed medicine for curtailing the pathological effects of oxidative overload during RA, unlocking the opportunity for further investigation into the impact on other inflammatory cells, such as neutrophils.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"43 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
In this current study, the quality by design (QbD) concept is used for creating and validating a unique, resilient, accurate, and reliable spectrophotometric approach to quantify cefaclor (CEF) in injections. Fractional factorial design (FFD) was a design implemented to screen the initial parameters. Moreover, the variables went through the central composite design (CCD) to assess the dependency and optimize the design. Several measures were analyzed statistically to determine the appropriateness of the data obtained from the experiments. At 265 nm, by the use of ethanol, cefaclor displays an absorption maximum. Variables like screening, slit-width, and sampling interval were recognized as critical methods and again, evaluation was done by a CCD. A good linearity was produced for cefaclor in the range of 2 to 12 μg/mL, with R2>0.9993. The process was determined for being perfect, having a good average percent recovery (greater than 100%). According to ICH guidelines, validation of the developed method was performed. By implementing QbD principles, the spectrophotometric was created and designed to integrate the quality into the method. The process was manifested for being flexible and appropriate for identifying CEF in pharmaceuticals.
{"title":"Chemometric Assisted UV-Spectrophotometric Quantification of Cefaclor in Suspension Dosage Form","authors":"Kirtimaya Mishra, Budumuru Padmasri, Swetha Vegesna, Asra Jabeen, Abhilash Dash, Satyam Kumar, Diptimayee Jena","doi":"10.25258/ijpqa.14.3.46","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.46","url":null,"abstract":"In this current study, the quality by design (QbD) concept is used for creating and validating a unique, resilient, accurate, and reliable spectrophotometric approach to quantify cefaclor (CEF) in injections. Fractional factorial design (FFD) was a design implemented to screen the initial parameters. Moreover, the variables went through the central composite design (CCD) to assess the dependency and optimize the design. Several measures were analyzed statistically to determine the appropriateness of the data obtained from the experiments. At 265 nm, by the use of ethanol, cefaclor displays an absorption maximum. Variables like screening, slit-width, and sampling interval were recognized as critical methods and again, evaluation was done by a CCD. A good linearity was produced for cefaclor in the range of 2 to 12 μg/mL, with R2>0.9993. The process was determined for being perfect, having a good average percent recovery (greater than 100%). According to ICH guidelines, validation of the developed method was performed. By implementing QbD principles, the spectrophotometric was created and designed to integrate the quality into the method. The process was manifested for being flexible and appropriate for identifying CEF in pharmaceuticals.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"32 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
An easy, accurate, and precise method used for simultaneous quantification of nirmatrelvir, ritonavir in bulk and marketed formulation by reverse phase high performance liquid chromatography (RP-HPLC) using a standard column Inertsil ODS (150 x 4.6 mm, 5 μm ) at a rate of flow 1-mL/min, acetonitrile and buffer containing hexane sulphonic acid, 50:50 v/v as a mobile phase was introduced through the HPLC column, detected at a wavelength 258 nm. Nirmatrelvir and ritonavir retention times were 2.481 and, 3.873 minutes, respectively. %Recovery rates for nirmatrelvir and ritonavir were 100 and 100.3%, respectively. LoD and LoQ values for nirmatrelvir and ritonavir were 1.5, 1 and 4.5, 3 g/mL, respectively. Nirmatrelvir regression equation is y = 32885.25x + 4223.04 while ritonavir is y = 39086.65x + 1680.21. Stability indicating studies done by acid, alkali, peroxide, Reduction, thermal, neutral and ultra violet light. The newly created reverse phase HPLC method, for bulk and marketed formulation, was rapid, stability indicating and accurate
{"title":"Development of a Simple Accurate Method, Validation and It’s Degradation Studies of Nirmatrelvir, Ritonavir in Bulk and Marketed Formulation by RP-HPLC","authors":"David Blessing Rani J, Asha Deepti C","doi":"10.25258/ijpqa.14.3.47","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.47","url":null,"abstract":"An easy, accurate, and precise method used for simultaneous quantification of nirmatrelvir, ritonavir in bulk and marketed formulation by reverse phase high performance liquid chromatography (RP-HPLC) using a standard column Inertsil ODS (150 x 4.6 mm, 5 μm ) at a rate of flow 1-mL/min, acetonitrile and buffer containing hexane sulphonic acid, 50:50 v/v as a mobile phase was introduced through the HPLC column, detected at a wavelength 258 nm. Nirmatrelvir and ritonavir retention times were 2.481 and, 3.873 minutes, respectively. %Recovery rates for nirmatrelvir and ritonavir were 100 and 100.3%, respectively. LoD and LoQ values for nirmatrelvir and ritonavir were 1.5, 1 and 4.5, 3 g/mL, respectively. Nirmatrelvir regression equation is y = 32885.25x + 4223.04 while ritonavir is y = 39086.65x + 1680.21. Stability indicating studies done by acid, alkali, peroxide, Reduction, thermal, neutral and ultra violet light. The newly created reverse phase HPLC method, for bulk and marketed formulation, was rapid, stability indicating and accurate","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"2014 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Medical devices are thought to be a blessing for the healthcare system because they are tools that can save lives. Apart from therapeutic potential, these devices have lot of negative side effects. It took a strong cohort attentive system to control such negative impacts. As a result, materiovigilance was introduced. Materiovigilance is the investigation and monitoring of incidents brought on by the use of medical devices. It controls adverse events (AE) and brings about international harmony. These goals are kept in mind when the principles, viewpoints, and materiovigilance techniques in the USA, Europe, China, Japan, Australia, Canada, and India are contrasted. It is crucial to make this comparison to comprehend the shortcomings of the current regulatory frameworks in the nations described above. Additionally, it will give the regulatory authorities a complete picture so they can alter any existing legislation as necessary. In the present study, an ideal proposed model of medical devices for its approval has been explained easily
{"title":"Comparative Materiovigilance Program for US, Europe, Japan, India and Proposed Reporting Mechanism for Indian Scenario","authors":"Manvendra S. Teli, Vikas Jhawat","doi":"10.25258/ijpqa.14.3.12","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.12","url":null,"abstract":"Medical devices are thought to be a blessing for the healthcare system because they are tools that can save lives. Apart from therapeutic potential, these devices have lot of negative side effects. It took a strong cohort attentive system to control such negative impacts. As a result, materiovigilance was introduced. Materiovigilance is the investigation and monitoring of incidents brought on by the use of medical devices. It controls adverse events (AE) and brings about international harmony. These goals are kept in mind when the principles, viewpoints, and materiovigilance techniques in the USA, Europe, China, Japan, Australia, Canada, and India are contrasted. It is crucial to make this comparison to comprehend the shortcomings of the current regulatory frameworks in the nations described above. Additionally, it will give the regulatory authorities a complete picture so they can alter any existing legislation as necessary. In the present study, an ideal proposed model of medical devices for its approval has been explained easily","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867778","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
The photodegradation study of ornidazole in an aqueous solution was performed by using the multivariate curve resolution-alternative least square technique. The sample solution was exposed to direct sunlight for 42 hours, and the spectroscopic data was obtained at predetermined intervals of wavelengths. MCR-ALS, which is a chemometric technique, was applied to the data set. Initially, soft modeling was used, followed by hard modeling. The results show that ornidazole undergoes photodegradation via a two-step process in an aqueous medium, with three species involved in the degradation process. The initial concentration of pure ornidazole decreases while the concentration of intermediate start increasing and the concentration of intermediate falls with the formation of a new product. Thus, we have got three pure spectra in the MCR-ALS process. The reaction kinetics was performed with the hard modeling technique using kinetic constrain and the rate constant of the reaction was found to be k1 = 0.0955 and k2 = 1.287, respectively.
{"title":"Chemometric Exploration of Photostability of Ornidazole in Aqueous Solution with Soft and Hard Modelling Multivariate Curve Resolution Method","authors":"Abhijeet Sutar, Tejas Dhole, Shruti Ringe, Shounak Kulkarni","doi":"10.25258/ijpqa.14.3.27","DOIUrl":"https://doi.org/10.25258/ijpqa.14.3.27","url":null,"abstract":"The photodegradation study of ornidazole in an aqueous solution was performed by using the multivariate curve resolution-alternative least square technique. The sample solution was exposed to direct sunlight for 42 hours, and the spectroscopic data was obtained at predetermined intervals of wavelengths. MCR-ALS, which is a chemometric technique, was applied to the data set. Initially, soft modeling was used, followed by hard modeling. The results show that ornidazole undergoes photodegradation via a two-step process in an aqueous medium, with three species involved in the degradation process. The initial concentration of pure ornidazole decreases while the concentration of intermediate start increasing and the concentration of intermediate falls with the formation of a new product. Thus, we have got three pure spectra in the MCR-ALS process. The reaction kinetics was performed with the hard modeling technique using kinetic constrain and the rate constant of the reaction was found to be k1 = 0.0955 and k2 = 1.287, respectively.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":"31 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135867832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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