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

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 × 4.6mm × 5μ) column with the mobile phase consisting of 0.02 mM sodium dihydrogen ortho-ph...

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Detalles Bibliográficos
Autores principales: Rao, KS, Jena, N, Rao, MEB
Formato: Texto
Lenguaje:English
Publicado: Medknow Publications 2010
Materias:
Pharmaceutical Analysis
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3021695/
https://www.ncbi.nlm.nih.gov/pubmed/21264123
http://dx.doi.org/10.4103/0975-1483.63166
Descripción
Sumario: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 × 4.6mm × 5μ) 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.

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