{"title":"克唑替尼的RP-HPLC分析方法的建立与验证","authors":"P. Putta","doi":"10.18689/ijbp-1000101","DOIUrl":null,"url":null,"abstract":"A simple, précised, accurate method was developed for the estimation of Crizotinib by RP-HPLC technique. Chromatographic conditions used are stationary phase BDS 250 × 4.6 mm, 5 μ. Mobile phase buffer: Acetonitrile in the ratio of 60:40 and flow rate was maintained at 1 ml/min, detection wave length was 267 nm, column temperature was set to 30°C and diluents was methanol: water. System suitability parameters were studied by injecting the standard five times and results were well (50:50), conditions were finalized as optimized method under acceptance criteria. Linearity study was carried out between 25% to 150% levels, r2 value was found to be as 0.999. Precision was found to be 1.26 for repeatability and 0.93 for intermediate precision. LOD and LOQ are 0.080 μg/ml. By using above method assay of marketed formulation was carried out 100.24% was present.","PeriodicalId":332720,"journal":{"name":"International Journal of Biochemistry and Pharmacology","volume":"54 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2019-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"title\":\"Analytical methods Development and Validation of Crizotinib by RP-HPLC Technique\",\"authors\":\"P. Putta\",\"doi\":\"10.18689/ijbp-1000101\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A simple, précised, accurate method was developed for the estimation of Crizotinib by RP-HPLC technique. Chromatographic conditions used are stationary phase BDS 250 × 4.6 mm, 5 μ. Mobile phase buffer: Acetonitrile in the ratio of 60:40 and flow rate was maintained at 1 ml/min, detection wave length was 267 nm, column temperature was set to 30°C and diluents was methanol: water. System suitability parameters were studied by injecting the standard five times and results were well (50:50), conditions were finalized as optimized method under acceptance criteria. Linearity study was carried out between 25% to 150% levels, r2 value was found to be as 0.999. Precision was found to be 1.26 for repeatability and 0.93 for intermediate precision. LOD and LOQ are 0.080 μg/ml. By using above method assay of marketed formulation was carried out 100.24% was present.\",\"PeriodicalId\":332720,\"journal\":{\"name\":\"International Journal of Biochemistry and Pharmacology\",\"volume\":\"54 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2019-01-28\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Biochemistry and Pharmacology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.18689/ijbp-1000101\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Biochemistry and Pharmacology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.18689/ijbp-1000101","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Analytical methods Development and Validation of Crizotinib by RP-HPLC Technique
A simple, précised, accurate method was developed for the estimation of Crizotinib by RP-HPLC technique. Chromatographic conditions used are stationary phase BDS 250 × 4.6 mm, 5 μ. Mobile phase buffer: Acetonitrile in the ratio of 60:40 and flow rate was maintained at 1 ml/min, detection wave length was 267 nm, column temperature was set to 30°C and diluents was methanol: water. System suitability parameters were studied by injecting the standard five times and results were well (50:50), conditions were finalized as optimized method under acceptance criteria. Linearity study was carried out between 25% to 150% levels, r2 value was found to be as 0.999. Precision was found to be 1.26 for repeatability and 0.93 for intermediate precision. LOD and LOQ are 0.080 μg/ml. By using above method assay of marketed formulation was carried out 100.24% was present.
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