Development and Validation of a Specific Stability Indicating High Performance Liquid Chromatographic Method for Valsartan

被引：19

作者：

Rao, K. S. ^{[1
]}

Jena, N. ^{[1
]}

Rao, M. E. B. ^{[1
]}

机构：

[1] Roland Inst Pharmaceut Sci, Berhampur 760010, Orissa, India

来源：

JOURNAL OF YOUNG PHARMACISTS | 2010年 / 2卷 / 02期

关键词：

Assay; stress studies; validation; valsartan;

D O I：

10.4103/0975-1483.63166

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

A stability-indicating HPLC assay method has been developed and validated for valsartan in bulk drug and pharmaceutical dosage forms. An isocratic RP-HPLC was achieved on Waters 2695 using Symmetry C18 (250mm x 4.6mm x 5 mu) column with the mobile phase consisting of 0.02 mM sodium dihydrogen ortho-phosphate, pH adjusted to 2.5 using ortho-phosphoric acid (solvent A), and acetonitrile (solvent B) in the ratio of 58: 42 % v/v. The stress testing of valsartan was carried out under acidic, alkaline, oxidative, thermal, and photolytic conditions. Valsartan was well resolved from its degradation products. The proposed method was validated as per ICH guidelines. The method was found to be suitable for the quality control of valsartan in bulk and pharmaceutical dosage forms as well as the stability-indicating studies.

引用

页码：183 / 189

页数：7

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