Separation and quantification of eight antidiabetic drugs on a high-performance liquid chromatography: its application to human plasma assay.

ISRN Pharmaceutics Pub Date : 2011-01-01 Epub Date: 2011-07-12 DOI:10.5402/2011/521353

Karunanidhi S Lakshmi, Tirumala Rajesh

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引用次数: 25

Abstract

An analytical method based on isocratic reverse phase high-performance liquid chromatography was developed and validated for the separation and quantification of eight antidiabetic drugs: rosiglitazone, pioglitazone, glipizide, gliclazide, repaglinide, nateglinide, glibenclamide, and glimepiride for their application in human plasma assay. Metformin is used as internal standard. Analysis was done on Onyx monolithic C(18) column (100 × 4.6 mm, i.d., 5 μm) using a mixture of 0.05% formic acid in water and methanol in the ratio of 42 : 58 (v/v) fixed at a flow rate of 0.5 mL/min, and they were monitored at 234 nm. Separation was achieved in less than 20 min. The calibration curves were linear in the range of 50-2000 ng/mL. The method was validated for its recovery, intra- and interday precision, stability, specificity, and selectivity. Plasma samples were prepared using solid-phase extraction of analytes. Hence, the developed method was found to be suitable for the routine analysis of selected antidiabetic drugs in biological matrices.

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8种抗糖尿病药物的高效液相色谱分离与定量:在人血浆分析中的应用。

建立了一种基于等容反相高效液相色谱的分析方法，并对8种降糖药物罗格列酮、吡格列酮、格列吡嗪、格列齐特、瑞格列奈、那格列奈、格列本脲和格列美脲在人血浆检测中的应用进行了验证。二甲双胍作为内标。在Onyx单片C(18)色谱柱(100 × 4.6 mm，直径5 μm)上进行分析，采用0.05%甲酸与水和甲醇的混合物，比例为42:58 (v/v)，固定流速为0.5 mL/min，在234 nm处监测。分离在不到20分钟内完成。校正曲线在50 ~ 2000 ng/mL范围内呈线性关系。验证了该方法的回收率、内、日间精密度、稳定性、特异性和选择性。血浆样品的制备采用固相萃取分析物。因此，该方法适用于生物基质中选定的抗糖尿病药物的常规分析。

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ISRN Pharmaceutics

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