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用于测定生物流体中缬沙坦的色谱方法开发与验证

Chromatographic method development and validation for the determination of valsartan in biological fluid.

作者信息

Ghayas Sana, Shoaib Muhammad Harris, Siddiqui Fahad, Yousuf Rabia Ismail, Masood M Ali, Anjum Fakhsheena, Bushra Rabia, Bashir Lubna, Naz Shazia, Muhammad Iyad Naeem

机构信息

Department of Pharmaceutics, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.

Dow College of Pharmacy, Dow University of Health Sciences, Karachi, Pakistan.

出版信息

Pak J Pharm Sci. 2017 Nov;30(6(Supplementary)):2355-2362.

PMID:29188769
Abstract

A swift, precise and simple HPLC bioanalytical technique with UV detection was established and validated for quantitative estimation of valsartan in human plasma. The analyte was separated from plasma by protein precipitation with acetonitrile and chromatographically separated on Zorbax SB-C18 (5μm, 4.6mm × 15cm) column. The solvent mixture system consisting of acetonitrile, water and glacial acetic acid (40:59:1 v/v), was pumped using isocratic mode at 1mL/min flow rate. Samples' detection of drug was made spectrophotometrically at a wavelength of 264nm. The analyte response was instituted to be linear from 0.06 to 8μg/mL with a regression value of 0.999. The accuracy of the proposed method was ranged between 97.2-100.3% with 5% RSD. The analytical recovery (>95%) was consistently observed and satisfactory sample stability was also found at different environmental conditions. In conclusion the reported bio-analytical method is easy and robust that was successfully utilized in estimation of valsartan in a pharmacokinetic study.

摘要

建立了一种快速、精确且简单的带紫外检测的高效液相色谱生物分析技术,并对其进行验证,用于定量测定人血浆中的缬沙坦。通过用乙腈进行蛋白沉淀将分析物与血浆分离,并在Zorbax SB-C18(5μm,4.6mm×15cm)柱上进行色谱分离。由乙腈、水和冰醋酸(40:59:1 v/v)组成的混合溶剂系统,以等度模式以1mL/min的流速泵送。药物样品在264nm波长处进行分光光度检测。分析物响应在0.06至8μg/mL范围内呈线性,回归值为0.999。所提出方法的准确度在97.2-100.3%之间,相对标准偏差为5%。始终观察到分析回收率(>95%),并且在不同环境条件下也发现样品稳定性良好。总之,所报道的生物分析方法简便且稳健,已成功用于药代动力学研究中缬沙坦的测定。

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