S. Mondal, Goluguri Sunil Reddy, P. Mondal, V. Prathyusha, Aishwarya P Nair, S. Rahaman
{"title":"稳定性指示超高效液相色谱- pda法测定缬更昔洛韦散装和片剂的含量","authors":"S. Mondal, Goluguri Sunil Reddy, P. Mondal, V. Prathyusha, Aishwarya P Nair, S. Rahaman","doi":"10.5530/phm.2018.2.16","DOIUrl":null,"url":null,"abstract":"Background: The present article described about the systemic development of ultra-performance liquid chromatography (UPLC) method for the quantitative determination of valganciclovir in bulk and dosage form. The subsequent validation and degradation study was also performed. Methods: The chromatographic Separation was achieved with an HSS (100x2.1 mm, 1.8m).column with an isocratic mobile phase containing a mixture of 0.01N potassium dihydrogen orthophosphate and acetonitrile (55:45 v/v). The flow rate of the mobile phase was 0.3 ml/min with a column temperature of 30°C and detection wavelength at 254 nm. The developed method was validated according to the ICH guidelines with respect to linearity, accuracy, precision, specificity, detection limits and robustness. Results: The precision of the results, stated as the %RSD was below 1.0%. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The calibration curve was linear over a concentration range from 25 to 150 μg/ml with a correlation coefficient of 0.9997. The recovery of valganciclovir was found to be in the range of 98 to 102%, whereas the detection limits were found to be 0.933 and 2.827 μg/ml. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stability-indicating ability of the developed UPLC method. Conclusion: The method is validated according to the ICH guidelines and it is applied successfully for the determination of valganciclovir in tablets.","PeriodicalId":19960,"journal":{"name":"Pharmaceutical Methods","volume":"1 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2018-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"5","resultStr":"{\"title\":\"A New Stability Indicating Ultra Performance Liquid Chromatography-PDA Method for the Estimation of Valganciclovir in Bulk and Tablet Dosage Form\",\"authors\":\"S. Mondal, Goluguri Sunil Reddy, P. Mondal, V. Prathyusha, Aishwarya P Nair, S. Rahaman\",\"doi\":\"10.5530/phm.2018.2.16\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background: The present article described about the systemic development of ultra-performance liquid chromatography (UPLC) method for the quantitative determination of valganciclovir in bulk and dosage form. The subsequent validation and degradation study was also performed. Methods: The chromatographic Separation was achieved with an HSS (100x2.1 mm, 1.8m).column with an isocratic mobile phase containing a mixture of 0.01N potassium dihydrogen orthophosphate and acetonitrile (55:45 v/v). The flow rate of the mobile phase was 0.3 ml/min with a column temperature of 30°C and detection wavelength at 254 nm. The developed method was validated according to the ICH guidelines with respect to linearity, accuracy, precision, specificity, detection limits and robustness. Results: The precision of the results, stated as the %RSD was below 1.0%. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The calibration curve was linear over a concentration range from 25 to 150 μg/ml with a correlation coefficient of 0.9997. The recovery of valganciclovir was found to be in the range of 98 to 102%, whereas the detection limits were found to be 0.933 and 2.827 μg/ml. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stability-indicating ability of the developed UPLC method. Conclusion: The method is validated according to the ICH guidelines and it is applied successfully for the determination of valganciclovir in tablets.\",\"PeriodicalId\":19960,\"journal\":{\"name\":\"Pharmaceutical Methods\",\"volume\":\"1 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2018-08-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"5\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmaceutical Methods\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5530/phm.2018.2.16\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Methods","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5530/phm.2018.2.16","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
A New Stability Indicating Ultra Performance Liquid Chromatography-PDA Method for the Estimation of Valganciclovir in Bulk and Tablet Dosage Form
Background: The present article described about the systemic development of ultra-performance liquid chromatography (UPLC) method for the quantitative determination of valganciclovir in bulk and dosage form. The subsequent validation and degradation study was also performed. Methods: The chromatographic Separation was achieved with an HSS (100x2.1 mm, 1.8m).column with an isocratic mobile phase containing a mixture of 0.01N potassium dihydrogen orthophosphate and acetonitrile (55:45 v/v). The flow rate of the mobile phase was 0.3 ml/min with a column temperature of 30°C and detection wavelength at 254 nm. The developed method was validated according to the ICH guidelines with respect to linearity, accuracy, precision, specificity, detection limits and robustness. Results: The precision of the results, stated as the %RSD was below 1.0%. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The calibration curve was linear over a concentration range from 25 to 150 μg/ml with a correlation coefficient of 0.9997. The recovery of valganciclovir was found to be in the range of 98 to 102%, whereas the detection limits were found to be 0.933 and 2.827 μg/ml. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stability-indicating ability of the developed UPLC method. Conclusion: The method is validated according to the ICH guidelines and it is applied successfully for the determination of valganciclovir in tablets.