Evrim Kepekci Tekkeli, I. Gazioğlu, Gizem Tırıs, C. Önal
{"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}
引用次数: 0
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.