Asian Journal of Pharmaceutical Analysis

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Method Development and Validation of Valsartan and Its Impurities by High Performance Liquid Chromatography


Affiliations
1 Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam, Andhra Pradesh, 530045, India
     

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Our main objective is to develop an accurate and precise 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. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation. The developed method can be utilized in the analysis of valsartan tablets.

Keywords

HPLC, Method Validation, Related Impurities, Entacapone, LOQ, LOD.
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  • Method Development and Validation of Valsartan and Its Impurities by High Performance Liquid Chromatography

Abstract Views: 324  |  PDF Views: 5

Authors

O. S. S. Chandana
Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam, Andhra Pradesh, 530045, India
R. Ravichandra Babu
Department of Chemistry, Institute of Science, GITAM University, Visakhapatnam, Andhra Pradesh, 530045, India

Abstract


Our main objective is to develop an accurate and precise 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. Linearity, accuracy, precision and robustness parameters for the suggested method were estimated for validation. The developed method can be utilized in the analysis of valsartan tablets.

Keywords


HPLC, Method Validation, Related Impurities, Entacapone, LOQ, LOD.