{"title":"紫外光谱法测定泊沙康唑原料药和制剂含量的建立与验证","authors":"Shivprasad Patil, Ajay Kshirsagar, Kartik Ade, Akash Bharkade, Madhav Bharkade, Ashish Birkalwar, Mahesh Chandolkar","doi":"10.52711/2231-5675.2023.00027","DOIUrl":null,"url":null,"abstract":"The present study was undertaken to develop a spectrophotometric method for the determination of Posaconazole (PCZ) in pharmaceutical dosage forms. This paper describes a simple, rapid, accurate, and precise UV-spectrophotometric method for the assay of PCZin bulk and marketed dosage forms. The validation of the developed method was carried out according to ICH guidelines concerning linearity, precision, accuracy, specificity, the limit of detection, and the limit of quantification. The diluent is aqueous methanol. Calibration curves were obtained in the concentration range of 04-20µg/ml for PCZ and with good correlation coefficients (R2=0.9981). The precisions of the new method for the drug were less than the maximum allowable limit (%RSD < 2.0) specified by the ICH. Therefore, the method was found to be accurate, reproducible, and sensitive for the analysis of PCZ in pharmaceutical dosage forms.","PeriodicalId":8547,"journal":{"name":"Asian Journal of Pharmaceutical Analysis","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Development and Validation of UV Spectroscopy Method for the Determination of Posaconazole in Bulk and Formulation\",\"authors\":\"Shivprasad Patil, Ajay Kshirsagar, Kartik Ade, Akash Bharkade, Madhav Bharkade, Ashish Birkalwar, Mahesh Chandolkar\",\"doi\":\"10.52711/2231-5675.2023.00027\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The present study was undertaken to develop a spectrophotometric method for the determination of Posaconazole (PCZ) in pharmaceutical dosage forms. This paper describes a simple, rapid, accurate, and precise UV-spectrophotometric method for the assay of PCZin bulk and marketed dosage forms. The validation of the developed method was carried out according to ICH guidelines concerning linearity, precision, accuracy, specificity, the limit of detection, and the limit of quantification. The diluent is aqueous methanol. Calibration curves were obtained in the concentration range of 04-20µg/ml for PCZ and with good correlation coefficients (R2=0.9981). The precisions of the new method for the drug were less than the maximum allowable limit (%RSD < 2.0) specified by the ICH. Therefore, the method was found to be accurate, reproducible, and sensitive for the analysis of PCZ in pharmaceutical dosage forms.\",\"PeriodicalId\":8547,\"journal\":{\"name\":\"Asian Journal of Pharmaceutical Analysis\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-09-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Asian Journal of Pharmaceutical Analysis\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.52711/2231-5675.2023.00027\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Asian Journal of Pharmaceutical Analysis","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.52711/2231-5675.2023.00027","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Development and Validation of UV Spectroscopy Method for the Determination of Posaconazole in Bulk and Formulation
The present study was undertaken to develop a spectrophotometric method for the determination of Posaconazole (PCZ) in pharmaceutical dosage forms. This paper describes a simple, rapid, accurate, and precise UV-spectrophotometric method for the assay of PCZin bulk and marketed dosage forms. The validation of the developed method was carried out according to ICH guidelines concerning linearity, precision, accuracy, specificity, the limit of detection, and the limit of quantification. The diluent is aqueous methanol. Calibration curves were obtained in the concentration range of 04-20µg/ml for PCZ and with good correlation coefficients (R2=0.9981). The precisions of the new method for the drug were less than the maximum allowable limit (%RSD < 2.0) specified by the ICH. Therefore, the method was found to be accurate, reproducible, and sensitive for the analysis of PCZ in pharmaceutical dosage forms.
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