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高效液相色谱法分离和定量测定八种抗糖尿病药物:其在人血浆分析中的应用

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

作者信息

Lakshmi Karunanidhi S, Rajesh Tirumala

机构信息

Department of Pharmaceutical Analysis, SRM College of Pharmacy, SRM University, Kattankulathur, Tamil Nadu 603203, India.

出版信息

ISRN Pharm. 2011;2011:521353. doi: 10.5402/2011/521353. Epub 2011 Jul 12.

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.

摘要

建立了一种基于等度反相高效液相色谱的分析方法,并对其进行了验证,用于分离和定量测定罗格列酮、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这八种抗糖尿病药物,以用于人体血浆分析。二甲双胍用作内标。采用Onyx整体式C(18)柱(100×4.6 mm,内径,5 μm)进行分析,使用0.05%甲酸水溶液和甲醇按42 : 58 (v/v)的比例混合,流速固定为0.5 mL/min,并在234 nm波长处进行监测。在不到20 分钟内实现了分离。校准曲线在50 - 2000 ng/mL范围内呈线性。该方法在回收率、日内和日间精密度、稳定性、特异性和选择性方面均得到验证。血浆样品采用分析物固相萃取法制备。因此,所建立的方法适用于生物基质中所选抗糖尿病药物的常规分析。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aeae/3263720/47bd99d5dc46/PHARMACEUTICS2011-521353.001.jpg

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