High performance liquid chromatographic analysis of lercanidipine in human breast milk

IF 1.8 Q3 CHEMISTRY, ANALYTICAL Journal of Chemical Metrology Pub Date : 2019-06-23 DOI:10.25135/JCM.23.19.03.1223
Evrim Kepekci Tekkeli, I. Gazioğlu, Gizem Tırıs, C. Önal
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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.
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人母乳中雷卡尼地平的高效液相色谱分析
建立了一种简便、快速、精密、准确的等度反相高效液相色谱法测定片剂和母乳中盐酸乐卡地平的含量。色谱分离在C18(250×4.6mm×5μm)柱上实现,流动相由乙腈和磷酸缓冲液(pH=4)(55:45,v/v)组成,流速为1.1mL/min,紫外检测波长为237nm。研究了所提出方法在1.0-40μg/mL范围内的线性(r=0.9990)。根据ICH指南,该方法在准确性、精密度、再现性、特异性、稳健性以及检测和定量限方面得到了验证。该方法适用于母乳中乐卡地平的常规定量。
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来源期刊
Journal of Chemical Metrology
Journal of Chemical Metrology CHEMISTRY, ANALYTICAL-
CiteScore
2.30
自引率
15.40%
发文量
7
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