The aim of the present investigation was to develop, validate and compare a UV spectrophotometric and a high performance liquid chromatography method for estimating Ticagrelor in bulk and tablet dosage form. Spectrophotometry and high performance liquid chromatography were carried out using standard instrumental parameters, which were optimized. Both methods were validated in terms of linearity, accuracy, precision, robustness, ruggedness and stability according to the ICH guidelines. The optimized ratio of mobile phase in high performance liquid chromatography under low pressure gradient mode was 30:70 % v/v of acetonitrile:glacial acetic acid 1 % , which provide a sharp peak with a short retention time of 3.910 minutes. In UV spectrophotometric analysis iso-propyl alcohol as a solvent gave adequate molar absorptivity at a λmax of 306 nm. Results indicated that both UV spectrophotometric and high performance liquid chromatography methods were linear, precise, accurate, rugged and robust with RSD values less than 2 % and percent recovery was within the standard limits (90-110 %). Both the methods were found to be statistically non-significant at 95 % confidence intervals (p<0.05) with respect to each other. The proposed methods were found to be highly effective and could be used for quantification of Ticagrelor in bulk and a tablet formulations for routine analysis.
{"title":"UV Spectrophotometric and HPLC Method for Quantification of Ticagrelor in Bulk and Tablet Dosage Form","authors":"Ravinder Bairam, Hemant Kumar Tatapudi, Neelama Gajji, Shaik Harun Rasheed","doi":"10.52711/2231-5675.2022.00027","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00027","url":null,"abstract":"The aim of the present investigation was to develop, validate and compare a UV spectrophotometric and a high performance liquid chromatography method for estimating Ticagrelor in bulk and tablet dosage form. Spectrophotometry and high performance liquid chromatography were carried out using standard instrumental parameters, which were optimized. Both methods were validated in terms of linearity, accuracy, precision, robustness, ruggedness and stability according to the ICH guidelines. The optimized ratio of mobile phase in high performance liquid chromatography under low pressure gradient mode was 30:70 % v/v of acetonitrile:glacial acetic acid 1 % , which provide a sharp peak with a short retention time of 3.910 minutes. In UV spectrophotometric analysis iso-propyl alcohol as a solvent gave adequate molar absorptivity at a λmax of 306 nm. Results indicated that both UV spectrophotometric and high performance liquid chromatography methods were linear, precise, accurate, rugged and robust with RSD values less than 2 % and percent recovery was within the standard limits (90-110 %). Both the methods were found to be statistically non-significant at 95 % confidence intervals (p<0.05) with respect to each other. The proposed methods were found to be highly effective and could be used for quantification of Ticagrelor in bulk and a tablet formulations for routine analysis.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"105 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79435482","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}
Pub Date : 2022-08-12DOI: 10.52711/2231-5675.2022.00029
A. Rehman, Pasupathi Nath Tiwari, Sreenivasa Rao
A rapid and highly sensitive high performance liquid chromatographic method has been developed for the determination of Safinamide Mesylate in bulk and in tablet dosage form. Safinamide mesylate was eluted from a XBridge C18 (250mmX4.6mm) reversed phase column with a mobile phase of Ammonium acetate buffer pH 5.8 and Acetonitrile in the ratio of 55:45 (v/v) at a flow rate of 1ml/min with UV detection of 26nm. The retention time for Safinamide mesylate was 3.8min. The linear response (r2 = 0.997) was observed in the range of 10-60 µg/ml with limits of detection (LOD) and quantification (LOQ) being 2.85 and 9.5µg/ml respectively. The method shows good recoveries and intra and inter-day relative standard deviations were less than 2%. Validation parameters as Specificity, accuracy, ruggedness and robustness were also determined. The proposed method provides accurate and precise quality control tool for routine of Safinamide mesylate in bulk and in tablet dosage form.
{"title":"Development and Validation of an RP-HPLC Method for the determination of Safinamide Mesylate in Bulk and Pharmaceutical Dosage Form","authors":"A. Rehman, Pasupathi Nath Tiwari, Sreenivasa Rao","doi":"10.52711/2231-5675.2022.00029","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00029","url":null,"abstract":"A rapid and highly sensitive high performance liquid chromatographic method has been developed for the determination of Safinamide Mesylate in bulk and in tablet dosage form. Safinamide mesylate was eluted from a XBridge C18 (250mmX4.6mm) reversed phase column with a mobile phase of Ammonium acetate buffer pH 5.8 and Acetonitrile in the ratio of 55:45 (v/v) at a flow rate of 1ml/min with UV detection of 26nm. The retention time for Safinamide mesylate was 3.8min. The linear response (r2 = 0.997) was observed in the range of 10-60 µg/ml with limits of detection (LOD) and quantification (LOQ) being 2.85 and 9.5µg/ml respectively. The method shows good recoveries and intra and inter-day relative standard deviations were less than 2%. Validation parameters as Specificity, accuracy, ruggedness and robustness were also determined. The proposed method provides accurate and precise quality control tool for routine of Safinamide mesylate in bulk and in tablet dosage form.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"147 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74495492","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}
Pub Date : 2022-08-12DOI: 10.52711/2231-5675.2022.00033
Darshan A. Salade, Kishor S. Arote, P. Patil, Pankaj S. Patil, Amol R. Pawar
The goal of this review is to establish the significance of cleaning validation in the pharmaceutical industry. Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust, lubricants, raw materials, intermediates, etc. Cleaning procedure is the process of assuring that cleaning procedures effectively remove the potentially dangerous substances from equipments. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. It briefly provides an overview on mechanism of contamination, cleaning mechanisms, cleaning agents, procedure of cleaning, and sampling techniques.
{"title":"A Review on Pharmaceutical Cleaning Validation","authors":"Darshan A. Salade, Kishor S. Arote, P. Patil, Pankaj S. Patil, Amol R. Pawar","doi":"10.52711/2231-5675.2022.00033","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00033","url":null,"abstract":"The goal of this review is to establish the significance of cleaning validation in the pharmaceutical industry. Pharmaceutical product and active pharmaceutical ingredients (APIs) can be contaminated by other pharmaceutical products or APIs, by cleaning agents, by microorganisms or by other materials e.g. air borne particles, dust, lubricants, raw materials, intermediates, etc. Cleaning procedure is the process of assuring that cleaning procedures effectively remove the potentially dangerous substances from equipments. This can be minimized by proper cleaning of equipment, apparatus as well as the processing area. So it is necessary to validate the cleaning procedures to ensure safety, efficacy, quality of the subsequent batches of drug product and regulatory requirements in Pharmaceutical product manufacture. It briefly provides an overview on mechanism of contamination, cleaning mechanisms, cleaning agents, procedure of cleaning, and sampling techniques.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"18 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81181033","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}
Drug analysis is crucial in the discovery, production, and therapeutic use of pharmaceuticals. Standard analytical procedures for newer medications or formulations may not be available in Pharmacopoeias; thus, newer analytical methods that are accurate, precise, specific, linear, simple, and rapid must be developed. A rapid, simple, sensitive, precise, and cost-effective RP-UHPLC method was developed and validated for the determination of Teriflunomide Active Pharmaceutical Ingredient (API) in this study. The method involved determination of Teriflunomide by resolving on RP-UHPLC using Sunniest C18 (250mm × 4.6mm, 5μm) column, utilizing a mobile phase of ACN: Water in the ratio of 60:40 v/v. The mobile phase was delivered with an isocratic flow rate of 1.0ml/minute. Ultra violet detection was carried out at 210nm. The retention time was optimized to 4. 4 minutes. The linearity range of Teriflunomide 35 to 247µg/ml was found to obey linearity with a correlation coefficient of 0.999. The LOD and LOQ were found to be 1.61µg/ml and 4.90µg/ml respectively and precision data was found to be <2 %RSD. The percentage recovery range was found to be satisfied which is represented in the results. The robustness studies were performed by changing the flow rate and mobile phase compositions. The method was validated for system suitability, specificity, linearity, precision, accuracy, Limit of Detection, Limit of Quantification and robustness. The developed method can be applied for the quality control of commercial teriflunomide API.
{"title":"Analytical Method Development and Validation of Teriflunomide Active Pharmaceutical Ingredient by RP-UHPLC","authors":"Arun Maruti Kashid, Pranali Prakash Polshettiwar, Kshitija Maruti Bhosale","doi":"10.52711/2231-5675.2022.00028","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00028","url":null,"abstract":"Drug analysis is crucial in the discovery, production, and therapeutic use of pharmaceuticals. Standard analytical procedures for newer medications or formulations may not be available in Pharmacopoeias; thus, newer analytical methods that are accurate, precise, specific, linear, simple, and rapid must be developed. A rapid, simple, sensitive, precise, and cost-effective RP-UHPLC method was developed and validated for the determination of Teriflunomide Active Pharmaceutical Ingredient (API) in this study. The method involved determination of Teriflunomide by resolving on RP-UHPLC using Sunniest C18 (250mm × 4.6mm, 5μm) column, utilizing a mobile phase of ACN: Water in the ratio of 60:40 v/v. The mobile phase was delivered with an isocratic flow rate of 1.0ml/minute. Ultra violet detection was carried out at 210nm. The retention time was optimized to 4. 4 minutes. The linearity range of Teriflunomide 35 to 247µg/ml was found to obey linearity with a correlation coefficient of 0.999. The LOD and LOQ were found to be 1.61µg/ml and 4.90µg/ml respectively and precision data was found to be <2 %RSD. The percentage recovery range was found to be satisfied which is represented in the results. The robustness studies were performed by changing the flow rate and mobile phase compositions. The method was validated for system suitability, specificity, linearity, precision, accuracy, Limit of Detection, Limit of Quantification and robustness. The developed method can be applied for the quality control of commercial teriflunomide API.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84320372","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}
Pub Date : 2022-08-12DOI: 10.52711/2231-5675.2022.00031
Sandip T. Thoke, Umesh T. Jadhao, Gunesh N. Dhembre
A simple, specific, sensitive, rapid, precise, accurate and economical UV Spectrophotometric simultaneous equation method have been developed and validated for the routine estimation of Dolutegravir sodium and Rilpivirine Hydrochloride in bulk form. The Method A employs estimation of drugs by simultaneous equation method (SEM) using synthetic mixture of drugs. The absorption maxima of drugs were found to be at 259.20nm for Dolutegravir sodium and 305.80nm for Rilpivirine Hydrochloride. Both drugs followed the beer lamberts law in the range of 4-24µg/ml and 1-8µg/ml for DOL and RIL respectively. Methods are validated according to ICH guidelines and can be adopted for the routine analysis Dolutegravir sodium and Rilpivirine Hydrochloride in pure bulk form.
{"title":"Development and Validation of UV Spectrophotometric Methods for Simultaneous Estimation of Dolutegravir Sodium and Rilpivirine Hydrochloride in Pure Bulk Form","authors":"Sandip T. Thoke, Umesh T. Jadhao, Gunesh N. Dhembre","doi":"10.52711/2231-5675.2022.00031","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00031","url":null,"abstract":"A simple, specific, sensitive, rapid, precise, accurate and economical UV Spectrophotometric simultaneous equation method have been developed and validated for the routine estimation of Dolutegravir sodium and Rilpivirine Hydrochloride in bulk form. The Method A employs estimation of drugs by simultaneous equation method (SEM) using synthetic mixture of drugs. The absorption maxima of drugs were found to be at 259.20nm for Dolutegravir sodium and 305.80nm for Rilpivirine Hydrochloride. Both drugs followed the beer lamberts law in the range of 4-24µg/ml and 1-8µg/ml for DOL and RIL respectively. Methods are validated according to ICH guidelines and can be adopted for the routine analysis Dolutegravir sodium and Rilpivirine Hydrochloride in pure bulk form.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"78 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83639426","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}
Pub Date : 2022-08-12DOI: 10.52711/2231-5675.2022.00032
Disha L. Barad, Urvi J. Chotaliya, Nilesh K. Patel
Titanium Dioxide (TiO2) is widely used in food products and can be found in sauces, icings, and chewing gums as well as in personal care products such as pharmaceutical tablets and toothpaste. Tio2 particle added as a whitening agent to confectionary products, that is, chewing gum, candies, chocolate, and snacks. Titanium dioxide is found naturally in various crystal phases. It exists in different crystal structures. anatase, rutile, and brookite, or a mixture of these. The major routes of TiO2 NP exposure that have toxicological relevance in humans are inhalation, dermal, and oral exposure. for characterization of particle size, size distribution, crystallinity, and concentration of Tio2 particles were first extracted using an acid digestion method from food and separation, various analytical methods were applied. The present study focus on the analyzes qualitative and quantitative trace element by using some analytical methods. TiO2 levels of investigated foods were determined by UV Spectroscopy, Inductively coupled plasma optical emission spectroscopy (ICP-OES), X-ray photoelectron spectroscopy, UV-Visible diffuse reflectance, Raman spectroscopy, Electron microscopy, X-ray diffraction (XRD), Gas volumetry, Laser diffraction, Laser droppler electrophorosis, FT-Raman, Spectroscopic analysis.
{"title":"A Brief Review on Titanium Dioxide","authors":"Disha L. Barad, Urvi J. Chotaliya, Nilesh K. Patel","doi":"10.52711/2231-5675.2022.00032","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00032","url":null,"abstract":"Titanium Dioxide (TiO2) is widely used in food products and can be found in sauces, icings, and chewing gums as well as in personal care products such as pharmaceutical tablets and toothpaste. Tio2 particle added as a whitening agent to confectionary products, that is, chewing gum, candies, chocolate, and snacks. Titanium dioxide is found naturally in various crystal phases. It exists in different crystal structures. anatase, rutile, and brookite, or a mixture of these. The major routes of TiO2 NP exposure that have toxicological relevance in humans are inhalation, dermal, and oral exposure. for characterization of particle size, size distribution, crystallinity, and concentration of Tio2 particles were first extracted using an acid digestion method from food and separation, various analytical methods were applied. The present study focus on the analyzes qualitative and quantitative trace element by using some analytical methods. TiO2 levels of investigated foods were determined by UV Spectroscopy, Inductively coupled plasma optical emission spectroscopy (ICP-OES), X-ray photoelectron spectroscopy, UV-Visible diffuse reflectance, Raman spectroscopy, Electron microscopy, X-ray diffraction (XRD), Gas volumetry, Laser diffraction, Laser droppler electrophorosis, FT-Raman, Spectroscopic analysis.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74691482","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}
Pub Date : 2022-08-12DOI: 10.52711/2231-5675.2022.00030
Kamalakshi Krishnamurthy, T. Zin., Priyamvatha K., Mahadeva Rao. U. S., S. M.
Nicotine (C10 H14 N2) exists in all parts of the plant but notably in the leaves. Nicotiana tabacum, or cultivated tobacco, is an annually grown herbaceous plant of the Nicotiana genus. In this study a rapid and sensitive evaluation of Nicotine by Thin Layer Chromatography is carried out.
{"title":"Detection of Nicotine by a New System:","authors":"Kamalakshi Krishnamurthy, T. Zin., Priyamvatha K., Mahadeva Rao. U. S., S. M.","doi":"10.52711/2231-5675.2022.00030","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00030","url":null,"abstract":"Nicotine (C10 H14 N2) exists in all parts of the plant but notably in the leaves. Nicotiana tabacum, or cultivated tobacco, is an annually grown herbaceous plant of the Nicotiana genus. In this study a rapid and sensitive evaluation of Nicotine by Thin Layer Chromatography is carried out.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"2015 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87839338","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}
Pub Date : 2022-05-27DOI: 10.52711/2231-5675.2022.00016
G. Dyade, Bhushankumar Arve, Chaitanya Nimbalkar
Quality by design (QbD) is a systematic process for pharmaceutical development recommended by regulatory agencies like USFDA. Development of various pharmaceutical processes including analytical methods by applying Quality by design aids in ensuring the robustness of the method. An analytical method was developed for the estimation of fluvastatin by applying QbD approach by UV-VIS spectrophotometry. Solvent 0.1 N NaOH was utilised and 302.4 nm was the wavelength for measurement of absorbance. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of the drugs was ascertained over the conc range 5-40 mcg/ml (microgram/ml). The accuracy was found within acceptable limit with SD 0.05079-0.78188 %; and the precision study was shown acceptable data as % RSD 0.6259-0.6559 for FVT. The stability of the method was studied by minor variation in the wavelength and minor change in the normality of solvent. The developed method is rigid, robust and efficient for the estimation of FVT from the dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage. The analytical methods, developed based on the QbD concept are more robust and reduce the number of out of trend (OOT) and out of specification (OOS) results during the actual usage in quality control.
质量设计(QbD)是美国fda等监管机构推荐的药物开发系统过程。通过应用设计质量来开发各种制药工艺，包括分析方法，以确保方法的稳健性。建立了紫外-可见分光光度法定量测定氟伐他汀的分析方法。溶剂为0.1 N NaOH，吸光度测量波长为302.4 nm。研究了输入变量对光谱特征的影响，以选择关键参数，并根据ICH q2 R1监管指南验证了所开发的方法。在5-40 mcg/ml(微克/ml)范围内确定了药物的线性关系。准确度在可接受范围内，SD为0.05079 ~ 0.78188%;精密度研究显示，FVT的% RSD为0.6259-0.6559，可接受。通过波长的微小变化和溶剂正态性的微小变化来考察该方法的稳定性。该方法具有刚性、鲁棒性和效率高的特点。通过前期的风险评估和后期的设计空间界定，将QbD应用于构建刚性稳健方法。基于QbD概念开发的分析方法更具鲁棒性，在实际质量控制使用过程中减少了不合趋势(OOT)和不合规格(OOS)结果的数量。
{"title":"Implementation of QBD Approach in Analytical Method Development of Fluvastatin by UV-VIS Spectrophotometry","authors":"G. Dyade, Bhushankumar Arve, Chaitanya Nimbalkar","doi":"10.52711/2231-5675.2022.00016","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00016","url":null,"abstract":"Quality by design (QbD) is a systematic process for pharmaceutical development recommended by regulatory agencies like USFDA. Development of various pharmaceutical processes including analytical methods by applying Quality by design aids in ensuring the robustness of the method. An analytical method was developed for the estimation of fluvastatin by applying QbD approach by UV-VIS spectrophotometry. Solvent 0.1 N NaOH was utilised and 302.4 nm was the wavelength for measurement of absorbance. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of the drugs was ascertained over the conc range 5-40 mcg/ml (microgram/ml). The accuracy was found within acceptable limit with SD 0.05079-0.78188 %; and the precision study was shown acceptable data as % RSD 0.6259-0.6559 for FVT. The stability of the method was studied by minor variation in the wavelength and minor change in the normality of solvent. The developed method is rigid, robust and efficient for the estimation of FVT from the dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage. The analytical methods, developed based on the QbD concept are more robust and reduce the number of out of trend (OOT) and out of specification (OOS) results during the actual usage in quality control.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88224497","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}
Pub Date : 2022-05-27DOI: 10.52711/2231-5675.2022.00014
G. Gajeli, S. Kumbhar, G. Patel
A novel UV-Spectroscopy method was developed and validated for the estimation of L-glutathione in bulk and dosage form with congo red. The wavelength at which L-glutathione and congo red mixture product showed maximum absorption at 568nm in distilled water. The developed method range was found to be10-90µg/ml. The developed method validated for linearity, precision, range, limit of detection, the limit of quantification, robustness, specificity, system suitability. The regression equation was found to be y = 0.0045x + 0.121 with correlation coefficient R² = 0.9983. The limit of detection and the quantification limit was 5.05 µg/ml and 15.32 µg/ml respectively. The developed method was found to be linear, precise, robust, economical for the evaluation of L-glutathione in bulk and dosage form.
{"title":"Development and Validation of Novel UV Spectroscopy Method for the Estimation of L-Glutathione in Bulk and Formulation with Congo Red","authors":"G. Gajeli, S. Kumbhar, G. Patel","doi":"10.52711/2231-5675.2022.00014","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00014","url":null,"abstract":"A novel UV-Spectroscopy method was developed and validated for the estimation of L-glutathione in bulk and dosage form with congo red. The wavelength at which L-glutathione and congo red mixture product showed maximum absorption at 568nm in distilled water. The developed method range was found to be10-90µg/ml. The developed method validated for linearity, precision, range, limit of detection, the limit of quantification, robustness, specificity, system suitability. The regression equation was found to be y = 0.0045x + 0.121 with correlation coefficient R² = 0.9983. The limit of detection and the quantification limit was 5.05 µg/ml and 15.32 µg/ml respectively. The developed method was found to be linear, precise, robust, economical for the evaluation of L-glutathione in bulk and dosage form.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79499379","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}
Pub Date : 2022-05-27DOI: 10.52711/2231-5675.2022.00025
Ganesh R. Bharskar, S. Mankar, S. Siddheshwar
Curcumin natural chemical constituents extracted from Curcuma longa has been extensively studied because of its various pharmacological properties, such as anti-inflammatory, antioxidant, anti-proliferative, antitumor, antibiotic, antiprotozoal, immunomodulatory and anticarcinogenic effects. Analytical methods play an important role to describe physicochemical properties of drug. Several techniques for estimating curcumin in turmeric powder and pharmaceutical formulations have been developed to improve the demand for analytical methods of curcumin. Various analytical methods for estimating curcumin (spectrophotometric, chromatographic, capillary electrophoresis, and biosensor approaches) have been fully reviewed and discussed in this study.
{"title":"Analytical Methods for Estimation of Curcumin in Bulk, Pharmaceutical Formulation and in Biological Samples","authors":"Ganesh R. Bharskar, S. Mankar, S. Siddheshwar","doi":"10.52711/2231-5675.2022.00025","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00025","url":null,"abstract":"Curcumin natural chemical constituents extracted from Curcuma longa has been extensively studied because of its various pharmacological properties, such as anti-inflammatory, antioxidant, anti-proliferative, antitumor, antibiotic, antiprotozoal, immunomodulatory and anticarcinogenic effects. Analytical methods play an important role to describe physicochemical properties of drug. Several techniques for estimating curcumin in turmeric powder and pharmaceutical formulations have been developed to improve the demand for analytical methods of curcumin. Various analytical methods for estimating curcumin (spectrophotometric, chromatographic, capillary electrophoresis, and biosensor approaches) have been fully reviewed and discussed in this study.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"36 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77985299","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：