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Development and Validation of RP-HPLC method for quantification of Valsartan and its Pharmaceutical Formulations

A simple, rapid, sensitive, reverse phase isocratic RP-HPLC method was developed for determination of Valsartan and its pharmaceutical formulation. The method was carried out using C18 column [Agilent ODS UG 5 column, 250mm x 4.5mm] with mobile phase comprised of Acetonitrile: Phosphate buffer (70:30 v/v) with 1.0 ml / min flow rate was quite robust. The optimum wavelength for detection was 273 nm at which better detector response for the drug was obtained. The run time was set at 7 min and the retention time was 3.5 minutes. The method was validated for specificity, accuracy, precision, linearity, limit of detection, limit of quantification, robustness, solubility and stability. LOD and LOQ were found to be 1.83 μg/ml, 5.5 μg/ml respectively. The calibration curve was linear in the concentration range of 10-50 μg/ml with coefficient of correlation 0.9993. The percentage recovery for the valsartan was found to be 99.0-100.2 and the % RSD was found to be less than 2 %. The proposed method was successfully applied for quantitative determination of valsartan in tablet dosage forms.

Author(s): Nagakanyaka devi paladugu*, G. Devala Rao, Bonthu Satyanarayana, Deepthi Poloju

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