Bioanalytical method development and Validation for determination of efonidipine hydrochloride ethanolate in rat plasma by high-performance liquid chromatography: applications for pharmacokinetic study

Analytical Chemistry Letters Pub Date : 2023-07-04 DOI:10.1080/22297928.2023.2263012

Swati Bharati, Vinod Gaikwad, Bothiraja Chellampillai

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Abstract

Abstract Efonidipine hydrochloride ethanolate (EFE), a dihydropyridine calcium channel blocker, is used for the treatment of hypertension. To find the EFE in pre-clinical samples (rat plasma), an HPLC method was devised for the current experiment. The biological samples were prepared using the methanolic extraction procedure to eliminate solvent effects. Using a C18 column, a pH-adjusted mobile phase of methanol and water (90:10, v/v) at a flow rate of 1 mL/min, and UV detection at 252 nm were utilized for chromatographic separation. The retention time of EFE was found to be 5.2 min. The developed bioanalytical method was validated with different validation parameters. The validation parameter results are within the acceptable range of the International Council for Harmonization guidelines. The method was successfully employed to evaluate the pharmacokinetic properties in Wistar albino rats following a single oral administration of 10 mg/kg of EFE. Therefore, the simple method would make it possible to detect EFE quickly and affordably from biological material. GRAPHICAL ABSTRACT

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高效液相色谱法测定大鼠血浆中盐酸乙醇依非地平的生物分析方法开发与验证：在药代动力学研究中的应用

摘要盐酸乙醇依非地平（EFE）是一种二氢吡啶类钙通道阻滞剂，用于治疗高血压。为了检测临床前样品（大鼠血浆）中的 EFE，本实验设计了一种高效液相色谱法。生物样品采用甲醇提取法制备，以消除溶剂的影响。采用 C18 色谱柱，以甲醇和水（90:10, v/v）为流动相进行 pH 值调节，流速为 1 mL/min，紫外检测波长为 252 nm。EFE 的保留时间为 5.2 分钟。采用不同的验证参数对所开发的生物分析方法进行了验证。验证参数结果在国际协调理事会准则的可接受范围内。在 Wistar 白化大鼠单次口服 10 毫克/千克 EFE 后，该方法成功地用于评价其药代动力学特性。因此，该方法简便易行，可快速、经济地从生物材料中检测 EFE。图表摘要

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来源期刊

Analytical Chemistry Letters

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2.30

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