Pub Date : 2022-05-27DOI: 10.52711/2231-5675.2022.00026
Amit J. Vyas, Shalini Anilkumar Jha, A. Patel, AI Patel, S. R. Shah, D. Sheth
The article consists of brief review on Simultaneous equation method (Vierodt’s method). This method is applicable for estimation of those drugs whose spectra overlap properly I.e. If a sample contains two absorbing drug each of which absorbing at λmax of the other, it is possible to determine both drugs by technique of simultaneous equation method. This article consists of the list of various combined dosage form and food sample analyzed by Vierodt’s method with its wavelength, linearity range and choice of solvents. This method permits simple, rapid and direct determination of combined dosage form without prior separation and therefore can be used in routine analysis. Quantitative estimation is necessary before introduction of any drug into the market because if concentration is more in formulation it can lead to toxicity problem or if concentration is found less, then formulation will not be effective in prescribed dose.
{"title":"Review on Simultaneous Equation Method (Vierodt’s Method)","authors":"Amit J. Vyas, Shalini Anilkumar Jha, A. Patel, AI Patel, S. R. Shah, D. Sheth","doi":"10.52711/2231-5675.2022.00026","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00026","url":null,"abstract":"The article consists of brief review on Simultaneous equation method (Vierodt’s method). This method is applicable for estimation of those drugs whose spectra overlap properly I.e. If a sample contains two absorbing drug each of which absorbing at λmax of the other, it is possible to determine both drugs by technique of simultaneous equation method. This article consists of the list of various combined dosage form and food sample analyzed by Vierodt’s method with its wavelength, linearity range and choice of solvents. This method permits simple, rapid and direct determination of combined dosage form without prior separation and therefore can be used in routine analysis. Quantitative estimation is necessary before introduction of any drug into the market because if concentration is more in formulation it can lead to toxicity problem or if concentration is found less, then formulation will not be effective in prescribed dose.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74933385","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: 10.52711/2231-5675.2022.00023
Ashok B. Patel, Avadhi R. Bundheliya, Rushali V. Zala, Amit J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth
Dissolution testing is a critical methodology; widely utilized in the development of a new pharmaceutical product. The test, in its simplest form, consists of placing the formulation in a dissolution apparatus containing suitable dissolution medium. The BCS has been a predictive tool for assess the prospective effects of formulation on the human, drug oral bioavailability. When used in combination with in vitro dissolution tests, the BCS can maintain the prediction of in vivo product performance and the development. Filtration is critical in drug dissolution testing as filtration stops the dissolution process and allows for accurate quantitation through separation of dissolved and un-dissolved components. The objective of this investigation was to determine if other sinker shapes will influence the rate, extent, or variability of dissolution. Dissolution test is required to study the drug release from the dosage form and its in vivo performance. Dissolution test is used to asses the lot-to-lot quality of drug product. development and validation of dissolution procedure(s) and to provide practical approaches for determining specificity, linearity, range, accuracy, precision, LOD, LOQ and robustness of methods.
{"title":"A Brief Review on Dissolution Method Development","authors":"Ashok B. Patel, Avadhi R. Bundheliya, Rushali V. Zala, Amit J. Vyas, Nilesh K. Patel, Ajay I. Patel, Devang B. Sheth","doi":"10.52711/2231-5675.2022.00023","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00023","url":null,"abstract":"Dissolution testing is a critical methodology; widely utilized in the development of a new pharmaceutical product. The test, in its simplest form, consists of placing the formulation in a dissolution apparatus containing suitable dissolution medium. The BCS has been a predictive tool for assess the prospective effects of formulation on the human, drug oral bioavailability. When used in combination with in vitro dissolution tests, the BCS can maintain the prediction of in vivo product performance and the development. Filtration is critical in drug dissolution testing as filtration stops the dissolution process and allows for accurate quantitation through separation of dissolved and un-dissolved components. The objective of this investigation was to determine if other sinker shapes will influence the rate, extent, or variability of dissolution. Dissolution test is required to study the drug release from the dosage form and its in vivo performance. Dissolution test is used to asses the lot-to-lot quality of drug product. development and validation of dissolution procedure(s) and to provide practical approaches for determining specificity, linearity, range, accuracy, precision, LOD, LOQ and robustness of methods.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"149 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75181051","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: 10.52711/2231-5675.2022.00015
R. Sri, Soundarya Soundarya, K. B. Sri, S. M
A Simple and precise UV-spectroscopic method was developed for the determination of Imatinib Mesylate in its bulk and formulation. The developed method has been validated for various parameters like specificity, accuracy, linearity, robustness according to USP general chapter<1225> and ICH Q2R1 guidelines. Pure solution of Imatinib Mesylate was scanned in the whole range of UV region where it has shown the maximum absorbance at 258nm. The RSD values for method precision and intermediate precision were found to be well within the acceptance criteria and the series of dilutions were found to be linear (2-12ug/ml) where r2= 0.999 was the regression value. Limit of detection (0.2925μg/ml) and Limit of quantification (0.8977μg/ml) of IMT were established. Further, the drug has been subjected to various stress conditions, and percent degraded was reported. Drug solutions have shown stability on the benchtop for up to 8 hours and 72 hours when the solutions were refrigerated.
{"title":"Stability Indicating UV-Spectrophotometric Method Development and its Validation for the Determination of Imatinib Mesylate in Bulk and Formulation","authors":"R. Sri, Soundarya Soundarya, K. B. Sri, S. M","doi":"10.52711/2231-5675.2022.00015","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00015","url":null,"abstract":"A Simple and precise UV-spectroscopic method was developed for the determination of Imatinib Mesylate in its bulk and formulation. The developed method has been validated for various parameters like specificity, accuracy, linearity, robustness according to USP general chapter<1225> and ICH Q2R1 guidelines. Pure solution of Imatinib Mesylate was scanned in the whole range of UV region where it has shown the maximum absorbance at 258nm. The RSD values for method precision and intermediate precision were found to be well within the acceptance criteria and the series of dilutions were found to be linear (2-12ug/ml) where r2= 0.999 was the regression value. Limit of detection (0.2925μg/ml) and Limit of quantification (0.8977μg/ml) of IMT were established. Further, the drug has been subjected to various stress conditions, and percent degraded was reported. Drug solutions have shown stability on the benchtop for up to 8 hours and 72 hours when the solutions were refrigerated.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87728894","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: 10.52711/2231-5675.2022.00019
D. Mamata, Srinu Naik Sapavatu
New RP-HPLC method have been developed for simultaneous analysis of lamivudine and dolutegravir in pharmaceutical dosage forms and applied to stability studies of drugs. The title analytes were eluted rapidly with phosphate buffer (pH 5.0) and acetonitrile (60:40 v/v) on Std discovery C18 (150 x 4.6 mm, 5 µ) column. The detection was carried out using PDA detector at 260 nm. The solutions were chromatographed at a constant flow rate of 1 mL/min. Lamivudine and Dolutegravir were eluted at 2.37 min and 2.97 min respectively with good resolution. Method was validated as ICH guidelines. The linearity range of lamivudine and dolutegravir were found to be of 18.75 - 112.5 µg/mL and 3.125 - 18.75 µg/mL, respectively. The % RSD values (< 2) in precision studies indicates the reproducibility of method. The percentage recoveries were 100.17 % and 100.36 % respectively for lamivudine and dolutegravir, found to be within the limits. The proposed validated method was fruitfully applied for assay of formulation and stability studies of drugs under various stress conditions.
{"title":"RP-HPLC method for swift analysis of Lamivudine and Dolutegravir in formulation, stability studies","authors":"D. Mamata, Srinu Naik Sapavatu","doi":"10.52711/2231-5675.2022.00019","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00019","url":null,"abstract":"New RP-HPLC method have been developed for simultaneous analysis of lamivudine and dolutegravir in pharmaceutical dosage forms and applied to stability studies of drugs. The title analytes were eluted rapidly with phosphate buffer (pH 5.0) and acetonitrile (60:40 v/v) on Std discovery C18 (150 x 4.6 mm, 5 µ) column. The detection was carried out using PDA detector at 260 nm. The solutions were chromatographed at a constant flow rate of 1 mL/min. Lamivudine and Dolutegravir were eluted at 2.37 min and 2.97 min respectively with good resolution. Method was validated as ICH guidelines. The linearity range of lamivudine and dolutegravir were found to be of 18.75 - 112.5 µg/mL and 3.125 - 18.75 µg/mL, respectively. The % RSD values (< 2) in precision studies indicates the reproducibility of method. The percentage recoveries were 100.17 % and 100.36 % respectively for lamivudine and dolutegravir, found to be within the limits. The proposed validated method was fruitfully applied for assay of formulation and stability studies of drugs under various stress conditions.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79032234","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: 10.52711/2231-5675.2022.00024
Priyanka S. Sutar, Manojkumar K. Munde, Vijaya S. Vichare, Nilesh S. Kulkarni
The degradation of new drug ingredients and drug products in more severe settings than accelerated conditions is referred to as forced degradation research. Forced degradation experiments were carried out to demonstrate the specificity of stability-indicating methodologies, providing insight into degradation pathways and drug degradation products, and assisting in the understanding of degradation product structures., identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies Statins, a type of lipid-lowering medication, are the most commonly prescribed and are an example of an unstable drug. In the presence of high temperatures and humidity, statins are susceptible to hydrolysis. As a result, the review discusses various studies of statin drug forced degradation studies. To describe the drug's intrinsic stability, the terms atorvastatin, Fluvastatin, pitavastatin, ruvastatin, simvastatin, and pravastatin are used. assist the selection of formulations and packaging as well as proper storage conditions.
{"title":"Review on Forced Degradation Study of Statins","authors":"Priyanka S. Sutar, Manojkumar K. Munde, Vijaya S. Vichare, Nilesh S. Kulkarni","doi":"10.52711/2231-5675.2022.00024","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00024","url":null,"abstract":"The degradation of new drug ingredients and drug products in more severe settings than accelerated conditions is referred to as forced degradation research. Forced degradation experiments were carried out to demonstrate the specificity of stability-indicating methodologies, providing insight into degradation pathways and drug degradation products, and assisting in the understanding of degradation product structures., identifying degradation products that could be spontaneously generated during storage and use of drugs and to facilitate improvement in manufacturing process and formulation corresponding with accelerated stability studies Statins, a type of lipid-lowering medication, are the most commonly prescribed and are an example of an unstable drug. In the presence of high temperatures and humidity, statins are susceptible to hydrolysis. As a result, the review discusses various studies of statin drug forced degradation studies. To describe the drug's intrinsic stability, the terms atorvastatin, Fluvastatin, pitavastatin, ruvastatin, simvastatin, and pravastatin are used. assist the selection of formulations and packaging as well as proper storage conditions.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"77 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85997971","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: 10.52711/2231-5675.2022.00017
P. Priya, Archana Gahtori
Analytical method development and validation is important in development of pharmaceutical preparations. In present study a spectroscopic method for determination of Amlodipine besylate in pharmaceutical dosage form has been developed and validated. The wavelength maxima of Amlodipine besylate was found to be 360nm. Ethanol was used as a solvent. Amlodipine besylate obeys beers law in the concentration range of 5-40μg/ml. The line equation obtained is y = 0.0136x + 0.001 with correlation coefficient (r2) of 0.998. Interday, intraday variations were studied to determine the precision of the proposed method and was found to be with good precision as the %RSD was less than 2%. The assay of 2 different marketed formulation (A and B) has been performed and the % assay of A and B was found to be 98.3% and 99.2% respectively. The sensitivity of the method was determined by LOD and LOQ was found to be 0.08123µg/ml and 0.2461µg/ml respectively. The method employed the parameters like linearity, accuracy, precision, sensitivity, robustness, ruggedness and all the procedures were as per ICH guidelines.
{"title":"UV Spectrophotometric Method Development and Validation for Amlodipine Besylate in Bulk and Tablet Dosage Form","authors":"P. Priya, Archana Gahtori","doi":"10.52711/2231-5675.2022.00017","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00017","url":null,"abstract":"Analytical method development and validation is important in development of pharmaceutical preparations. In present study a spectroscopic method for determination of Amlodipine besylate in pharmaceutical dosage form has been developed and validated. The wavelength maxima of Amlodipine besylate was found to be 360nm. Ethanol was used as a solvent. Amlodipine besylate obeys beers law in the concentration range of 5-40μg/ml. The line equation obtained is y = 0.0136x + 0.001 with correlation coefficient (r2) of 0.998. Interday, intraday variations were studied to determine the precision of the proposed method and was found to be with good precision as the %RSD was less than 2%. The assay of 2 different marketed formulation (A and B) has been performed and the % assay of A and B was found to be 98.3% and 99.2% respectively. The sensitivity of the method was determined by LOD and LOQ was found to be 0.08123µg/ml and 0.2461µg/ml respectively. The method employed the parameters like linearity, accuracy, precision, sensitivity, robustness, ruggedness and all the procedures were as per ICH guidelines.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"55 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81674033","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: 10.52711/2231-5675.2022.00022
Sruthikrishna P.K., S. Shrikumar
Mesua ferrea Linn., commonly called Nagakesara or Ceylon iron wood belongs to the family Calophyllaceae. The present study deals with the Gas Chromatography Mass Spectroscopy analysis of Mesua ferrea, which have different medicinal properties. The aim of this study was to identify the phytocomponents present in the ethylacetate extract of Mesua ferrea by using Shimadzu GC-MS Model number: QP2010S equipped with Column - ELITE-5MS (30 meter length, 0.25 mm ID, and 0.25 µm thicknesses). Fourteen compounds were identified and which includes (-)-.alpha.-copaene, .alpha.-Bergamotene, (+)-valencene, beta-eudesmene, .alpha.-selinene, .beta.-Bisabolene, 2, 4-ditert-butylphenol, delta.-cadinene, neophytadiene, Phytol, .beta.-Resorcylic acid, 5-(3, 7-dimethyl-2, 6-octadienyl)-6-pentyl-, ethyl ester, (E)-, Squalene, nonadecane, tricosane.
{"title":"GC-MS analysis of phytocomponents in the ethylacetate extract of Mesua ferrea Linn. leaves","authors":"Sruthikrishna P.K., S. Shrikumar","doi":"10.52711/2231-5675.2022.00022","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00022","url":null,"abstract":"Mesua ferrea Linn., commonly called Nagakesara or Ceylon iron wood belongs to the family Calophyllaceae. The present study deals with the Gas Chromatography Mass Spectroscopy analysis of Mesua ferrea, which have different medicinal properties. The aim of this study was to identify the phytocomponents present in the ethylacetate extract of Mesua ferrea by using Shimadzu GC-MS Model number: QP2010S equipped with Column - ELITE-5MS (30 meter length, 0.25 mm ID, and 0.25 µm thicknesses). Fourteen compounds were identified and which includes (-)-.alpha.-copaene, .alpha.-Bergamotene, (+)-valencene, beta-eudesmene, .alpha.-selinene, .beta.-Bisabolene, 2, 4-ditert-butylphenol, delta.-cadinene, neophytadiene, Phytol, .beta.-Resorcylic acid, 5-(3, 7-dimethyl-2, 6-octadienyl)-6-pentyl-, ethyl ester, (E)-, Squalene, nonadecane, tricosane.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"124 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88627396","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 reverse phase high performance liquid chromatographic method has been developed for the estimation of Deferasirox in bulk and in tablet dosage form. Further optimized HPLC method was validated as per the current ICH guidelines. The experiment was conducted on a Inertsil ODS-3V C18, 150mm length, 4.6mm ID, and 5µm particle size column using the chromatographic separation was done with 60:40 v/v ratio of Acetonitrile and Buffer (0.05% Orthophosphoric Acid) as the mobile phase at a flow rate of 1.5mL min-1, and detection of component was made at 250nm. The HPLC method was accurate, with linearity ranging from 10.8 to 162µg/mL of Deferasirox, the correlation coeffient >0.999. The method was exposed to a high accuracy of more than 97%. The results disclose the successful applicability of the current process for the estimation of Deferasirox from its drug substance and marketed formulation, which can be consciously inferred to assess the other formulation systems. The developed method was validated in terms of linearity, accuracy, precision, LOD, LOQ, robustness & ruggedness. The proposed method can be helpful in Quality control laboratories for the determination of Deferasirox in the pharmaceutical dosage form.
{"title":"Development and Validation of Rapid RP-HPLC Method for determination of Deferasirox in Bulk and Tablet Dosage Forms","authors":"Santhosh Kumar Ettaboina, Komalatha Nakkala, Nayana Chathalingath","doi":"10.52711/2231-5675.2022.00013","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00013","url":null,"abstract":"The reverse phase high performance liquid chromatographic method has been developed for the estimation of Deferasirox in bulk and in tablet dosage form. Further optimized HPLC method was validated as per the current ICH guidelines. The experiment was conducted on a Inertsil ODS-3V C18, 150mm length, 4.6mm ID, and 5µm particle size column using the chromatographic separation was done with 60:40 v/v ratio of Acetonitrile and Buffer (0.05% Orthophosphoric Acid) as the mobile phase at a flow rate of 1.5mL min-1, and detection of component was made at 250nm. The HPLC method was accurate, with linearity ranging from 10.8 to 162µg/mL of Deferasirox, the correlation coeffient >0.999. The method was exposed to a high accuracy of more than 97%. The results disclose the successful applicability of the current process for the estimation of Deferasirox from its drug substance and marketed formulation, which can be consciously inferred to assess the other formulation systems. The developed method was validated in terms of linearity, accuracy, precision, LOD, LOQ, robustness & ruggedness. The proposed method can be helpful in Quality control laboratories for the determination of Deferasirox in the pharmaceutical dosage form.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"14 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74616592","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: 10.52711/2231-5675.2022.00021
S. Beula, T. Reddy, V. M., R. Y.
The present work describes a reverse phase high performance liquid chromatographic method (RP-HPLC) for the simultaneous estimation of Flupentixol and Melitracen in bulk and in tablet dosage form. Chromatographic separation was performed on Hypersil (C18) (250mm x 4.6mm, 5µm) Column, with a mobile phase comprising of a mixture of methanol and Acetonitrile in the ratio of 34:66v/v. The flow rate was 1.0ml/min with detection at 257nm. Retention times of Flupentixol and Melitracen were found to be 1.791min and 3.465min respectively. As per International Conference on Harmonization (ICH) guidelines the method was validated for linearity, accuracy, precision, limit of quantitation, limit of detection, and robustness. Linearity of Flupentixol was found to be in the range of 60-140µg/mL. and that for Melitracen was found to be 30-70µg/mL. The Precision (Repeatability, Intra-day and Inter-day) of the Flupentixol and Melitracen was found to be within the limits. The correlation coefficients were 0.999 and 0.999 for Flupentixol and Melitracen respectively. The mean recoveries obtained for Flupentixol and Melitracen were 100.28% and 99.79%. This demonstrates that the developed method is simple, precise, accurate, reproducible and rapid for simultaneous estimation of these drugs in bulk and in tablet dosage forms.
{"title":"Stability Indicating RP-HPLC Method Development and Validation for The Simultaneous Estimation of Flupentixol and Melitracen in API from and Marketed Tablet Dosage form","authors":"S. Beula, T. Reddy, V. M., R. Y.","doi":"10.52711/2231-5675.2022.00021","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00021","url":null,"abstract":"The present work describes a reverse phase high performance liquid chromatographic method (RP-HPLC) for the simultaneous estimation of Flupentixol and Melitracen in bulk and in tablet dosage form. Chromatographic separation was performed on Hypersil (C18) (250mm x 4.6mm, 5µm) Column, with a mobile phase comprising of a mixture of methanol and Acetonitrile in the ratio of 34:66v/v. The flow rate was 1.0ml/min with detection at 257nm. Retention times of Flupentixol and Melitracen were found to be 1.791min and 3.465min respectively. As per International Conference on Harmonization (ICH) guidelines the method was validated for linearity, accuracy, precision, limit of quantitation, limit of detection, and robustness. Linearity of Flupentixol was found to be in the range of 60-140µg/mL. and that for Melitracen was found to be 30-70µg/mL. The Precision (Repeatability, Intra-day and Inter-day) of the Flupentixol and Melitracen was found to be within the limits. The correlation coefficients were 0.999 and 0.999 for Flupentixol and Melitracen respectively. The mean recoveries obtained for Flupentixol and Melitracen were 100.28% and 99.79%. This demonstrates that the developed method is simple, precise, accurate, reproducible and rapid for simultaneous estimation of these drugs in bulk and in tablet dosage forms.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"40 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89211057","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: 10.52711/2231-5675.2022.00018
S. Patharkar, K. Gajbhiye, Nawaz Hakam, AM. Vyawahare
A rapid, sensitive and accurate method for Estimation of Anti- Histamine in Tablet Dosage Form by RP-HPLC. Mobile phase was Methanol: 0.1% Ortho phosphoric acid (80:20% v/v). Flow rate was 0.9 ml/min. The detection Wavelength was 227 nm. The injection volume was 20-µl. The proposed method was validated for selectivity, precision, linearity, and accuracy. All validation parameters were within the acceptable range. Linearity studies for Levamisole was performed (10-60µg/ml). The %RSD for accuracy found to be less than2%. Assay was found to be 99.17 to 101.65 respectively The range of 10-60µg /ml was selected for the linearity of a standard Levamisole. The 80%, 100% and 120% levels of recovery study were selected to perform the recovery study. Linearity studies for Levamisole was performed on (10-60µg /ml).
{"title":"Development and Validation of New Analytical Method for Estimation of Anthelmintic in Tablet Dosage Form","authors":"S. Patharkar, K. Gajbhiye, Nawaz Hakam, AM. Vyawahare","doi":"10.52711/2231-5675.2022.00018","DOIUrl":"https://doi.org/10.52711/2231-5675.2022.00018","url":null,"abstract":"A rapid, sensitive and accurate method for Estimation of Anti- Histamine in Tablet Dosage Form by RP-HPLC. Mobile phase was Methanol: 0.1% Ortho phosphoric acid (80:20% v/v). Flow rate was 0.9 ml/min. The detection Wavelength was 227 nm. The injection volume was 20-µl. The proposed method was validated for selectivity, precision, linearity, and accuracy. All validation parameters were within the acceptable range. Linearity studies for Levamisole was performed (10-60µg/ml). The %RSD for accuracy found to be less than2%. Assay was found to be 99.17 to 101.65 respectively The range of 10-60µg /ml was selected for the linearity of a standard Levamisole. The 80%, 100% and 120% levels of recovery study were selected to perform the recovery study. Linearity studies for Levamisole was performed on (10-60µg /ml).","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74231681","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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