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Asian Journal of Pharmaceutical Analysis
Year : 2020, Volume : 10, Issue : 2
First page : ( 103) Last page : ( 108)
Print ISSN : 2231-5667. Online ISSN : 2231-5675.
Article DOI : 10.5958/2231-5675.2020.00018.6

Assay Method Development and Validation for Valsartan using high Performance liquid Chromatography

Dr. Chandana O. S. S.*

Aditya College of Engineering, Surampalem, Andhra Pradesh, India-533437

*Corresponding Author E-mail: osschandana@gmail.com

Online published on 3 June, 2020.

Abstract

Our main objective is to develop a simple, accurate, precise and stability indicating HPLC method for the determination of valsartan and its impurities. An inertsil ODS-3v; (150 × 4.6) mm; 5 μm column is used for the separation of drugs. The flow rate was maintained at 1.0 mL/min and the wave length used for detection was 230 nm. The linearity was observed in the range of 0.025–50μg/ml of spiked impurities in valsartan, impurity B and impurity C with a correlation coefficient of 0.990, 0.996 and 0.997 respectively. The drug undergoes degradation under acid, base, H2O2, thermal and humidity conditions. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation as per ICH guidelines. The developed method can be utilized in the analysis of valsartan tablets.

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Keywords

Valsartan, HPLC, stability indicating, Validation, force degradation studies.

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