K. Patil, Swapnal Narkhede, Mahesh S Nemade, S. Rane, Rajesh Chaudhari, G. Dhobale, H. Tare
{"title":"一种高效液相色谱法测定原料药和制剂中依托昔布的含量","authors":"K. Patil, Swapnal Narkhede, Mahesh S Nemade, S. Rane, Rajesh Chaudhari, G. Dhobale, H. Tare","doi":"10.25258/ijpqa.14.2.19","DOIUrl":null,"url":null,"abstract":"Aim: The current research aims to create a high-resolution and validated liquid chromatographic method used for quantitative detection of etoricoxib within dosage forms that is both easy to use and reliable in terms of accuracy, sensitivity, and reproducibility. Materials and Methods: Analysis was carried out at isocratic conditions at flow rate of 0.7 mL/min using a mobile phase consisting of 40 parts methanol to 60 parts water (0.1% OPA) at pH 3.2. The eluents were tested using UV detection at 236 nm. Results: Etoricoxib had clearly separated peaks with a retention duration of 4.347 minutes in the optimized settings. The concentration range used to generate the calibration curve was 10 to 60 μg/mL. LoD was 0.0779 μg/mL, and upper LoQ was 0.23 μg/mL. The approach has been effective in separating a known quantity of etoricoxib, and the percentage of degradation was shown to be very low across all stress settings. Conclusion: Etoricoxib in bulk drug and commercial formulations can be identified and quantified using the proposed method, which has been validated in accordance with ICH recommendations.","PeriodicalId":14260,"journal":{"name":"International Journal of Pharmaceutical Quality Assurance","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":"{\"title\":\"A Validated Sensitive Stability Indicating HPLC Method for the Determination of Etoricoxib in Bulk and Formulation\",\"authors\":\"K. Patil, Swapnal Narkhede, Mahesh S Nemade, S. Rane, Rajesh Chaudhari, G. Dhobale, H. Tare\",\"doi\":\"10.25258/ijpqa.14.2.19\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Aim: The current research aims to create a high-resolution and validated liquid chromatographic method used for quantitative detection of etoricoxib within dosage forms that is both easy to use and reliable in terms of accuracy, sensitivity, and reproducibility. Materials and Methods: Analysis was carried out at isocratic conditions at flow rate of 0.7 mL/min using a mobile phase consisting of 40 parts methanol to 60 parts water (0.1% OPA) at pH 3.2. The eluents were tested using UV detection at 236 nm. Results: Etoricoxib had clearly separated peaks with a retention duration of 4.347 minutes in the optimized settings. The concentration range used to generate the calibration curve was 10 to 60 μg/mL. LoD was 0.0779 μg/mL, and upper LoQ was 0.23 μg/mL. The approach has been effective in separating a known quantity of etoricoxib, and the percentage of degradation was shown to be very low across all stress settings. Conclusion: Etoricoxib in bulk drug and commercial formulations can be identified and quantified using the proposed method, which has been validated in accordance with ICH recommendations.\",\"PeriodicalId\":14260,\"journal\":{\"name\":\"International Journal of Pharmaceutical Quality Assurance\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-06-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Pharmaceutical Quality Assurance\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.25258/ijpqa.14.2.19\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"Pharmacology, Toxicology and Pharmaceutics\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Pharmaceutical Quality Assurance","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.25258/ijpqa.14.2.19","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
A Validated Sensitive Stability Indicating HPLC Method for the Determination of Etoricoxib in Bulk and Formulation
Aim: The current research aims to create a high-resolution and validated liquid chromatographic method used for quantitative detection of etoricoxib within dosage forms that is both easy to use and reliable in terms of accuracy, sensitivity, and reproducibility. Materials and Methods: Analysis was carried out at isocratic conditions at flow rate of 0.7 mL/min using a mobile phase consisting of 40 parts methanol to 60 parts water (0.1% OPA) at pH 3.2. The eluents were tested using UV detection at 236 nm. Results: Etoricoxib had clearly separated peaks with a retention duration of 4.347 minutes in the optimized settings. The concentration range used to generate the calibration curve was 10 to 60 μg/mL. LoD was 0.0779 μg/mL, and upper LoQ was 0.23 μg/mL. The approach has been effective in separating a known quantity of etoricoxib, and the percentage of degradation was shown to be very low across all stress settings. Conclusion: Etoricoxib in bulk drug and commercial formulations can be identified and quantified using the proposed method, which has been validated in accordance with ICH recommendations.
期刊介绍:
INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE is a quarterly international journal publishing the finest peer-reviewed research in the field of Pharmaceutical Quality Assurance and Pharmaceutical Analysis on the basis of its originality, importance, disciplinary interest, timeliness, accessibility, elegance, and surprising conclusions. IJPQA also provides rapid, authoritative, insightful and arresting news and interpretation of topical and coming trends affecting science, scientists and the wider public.