高效液相色谱法同时定量分析血浆中奥美沙坦酯和苯磺酸氨氯地平

Simultaneous Quantitative Analysis of Olmesartan Medoxomil and Amlodipine Besylate in Plasma by High-performance Liquid Chromatography Technique.

作者信息

Shah S, Asnani A, Kawade D, Dangre S, Arora S, Yende S

机构信息

Department of Pharmaceutical Chemistry, Smt. Kishoritai Bhoyar College of Pharmacy, Nagpur, India.

出版信息

J Young Pharm. 2012 Apr;4(2):88-94. doi: 10.4103/0975-1483.96622.

DOI:10.4103/0975-1483.96622

PMID:22754260

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3385223/

Abstract

A rapid, simple and sensitive high-performance liquid chromatography (HPLC) method has been developed for quantification of olmesartan medoxomil (OLM) and amlodipine besylate (AM) in plasma. The assay enables the measurement of OLM and AM for therapeutic drug monitoring with a minimum detectable limit of 2 ng mL. The method involves a simple, one-step extraction procedure and analytical recovery was above 50%. The separation was performed on an analytical 250 × 4.6 mm Eurospher 100(-5) C18 column. The wavelength was set at 239 nm. The mobile phase was a mixture of acetonitrile:0.05 M ammonium acetate buffer: 0.1 mL triethylamine at pH 6.8 was selected at a flow rate of 1.0 mL min. The calibration curve for the determination of OLM and AM in plasma was linear over the range 2-2500 and 8-10,000 ng mL AM and OLM. The coefficients of variation for interday and intraday assay were found to be <15%. The method can be applied to a pharmacokinetic and pharmacodynamic study of OLM and AM in a combined dosage form.

摘要

已开发出一种快速、简单且灵敏的高效液相色谱（HPLC）方法，用于定量测定血浆中的奥美沙坦酯（OLM）和苯磺酸氨氯地平（AM）。该测定法能够测量OLM和AM以进行治疗药物监测，最低检测限为2 ng/mL。该方法涉及一个简单的一步萃取程序，分析回收率高于50%。分离在一根250×4.6 mm的Eurospher 100(-5) C18分析柱上进行。波长设定为239 nm。流动相为乙腈、0.05 M醋酸铵缓冲液和0.1 mL三乙胺（pH 6.8）的混合物，流速为1.0 mL/min。血浆中OLM和AM测定的校准曲线在2 - 2500 ng/mL的OLM和8 - 10,000 ng/mL的AM范围内呈线性。日间和日内测定的变异系数均<15%。该方法可应用于OLM和AM复方剂型的药代动力学和药效学研究。