Evrim Kepekci Tekkeli, I. Gazioğlu, Gizem Tırıs, C. Önal
{"title":"人母乳中雷卡尼地平的高效液相色谱分析","authors":"Evrim Kepekci Tekkeli, I. Gazioğlu, Gizem Tırıs, C. Önal","doi":"10.25135/JCM.23.19.03.1223","DOIUrl":null,"url":null,"abstract":"A simple, rapid, precise and accurate isocratic reversed phase HPLC method was developed and validated for the determination of lercanidipine hydrochloride in pharmaceutical tablets and spiked human breast milk. The chromatographic separation was achieved on C18 (250×4.6 mm×5μm) column using a mobile phase consisting of acetonitrile and phospate buffer (pH=4) (55:45, v/v) at a flow rate of 1.1 mL/min and UV detection at 237 nm. The linearity of the proposed method was investigated in the range of 1.0-40 μg/mL (r=0.9990). The method was validated in terms of accuracy, precision, reproducibility, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. The proposed method is found as suitable for routine quantification of lercanidipine in human breast milk.","PeriodicalId":15343,"journal":{"name":"Journal of Chemical Metrology","volume":null,"pages":null},"PeriodicalIF":1.8000,"publicationDate":"2019-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"High performance liquid chromatographic analysis of lercanidipine in human breast milk\",\"authors\":\"Evrim Kepekci Tekkeli, I. Gazioğlu, Gizem Tırıs, C. Önal\",\"doi\":\"10.25135/JCM.23.19.03.1223\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A simple, rapid, precise and accurate isocratic reversed phase HPLC method was developed and validated for the determination of lercanidipine hydrochloride in pharmaceutical tablets and spiked human breast milk. The chromatographic separation was achieved on C18 (250×4.6 mm×5μm) column using a mobile phase consisting of acetonitrile and phospate buffer (pH=4) (55:45, v/v) at a flow rate of 1.1 mL/min and UV detection at 237 nm. The linearity of the proposed method was investigated in the range of 1.0-40 μg/mL (r=0.9990). The method was validated in terms of accuracy, precision, reproducibility, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. The proposed method is found as suitable for routine quantification of lercanidipine in human breast milk.\",\"PeriodicalId\":15343,\"journal\":{\"name\":\"Journal of Chemical Metrology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2019-06-23\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Chemical Metrology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.25135/JCM.23.19.03.1223\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CHEMISTRY, ANALYTICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Chemical Metrology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.25135/JCM.23.19.03.1223","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
High performance liquid chromatographic analysis of lercanidipine in human breast milk
A simple, rapid, precise and accurate isocratic reversed phase HPLC method was developed and validated for the determination of lercanidipine hydrochloride in pharmaceutical tablets and spiked human breast milk. The chromatographic separation was achieved on C18 (250×4.6 mm×5μm) column using a mobile phase consisting of acetonitrile and phospate buffer (pH=4) (55:45, v/v) at a flow rate of 1.1 mL/min and UV detection at 237 nm. The linearity of the proposed method was investigated in the range of 1.0-40 μg/mL (r=0.9990). The method was validated in terms of accuracy, precision, reproducibility, specificity, robustness, and detection and quantification limits, in accordance with ICH guidelines. The proposed method is found as suitable for routine quantification of lercanidipine in human breast milk.