Revista de Ciências Biomédicas e Farmacêuticas

RP-HPLC Method Development and Validation of Valsartan in Bulk and its Tablet Dosage Form

Abstract

Pal Rekha, Padma Shree, Bhargav Y and Ram Reddy G

The main objective of this study is to develop a reverse phase HPLC method for the quantitative determination of valsartan and its tablet dosage form with a simple, rapid, specific, validated and sensitive method. An isocratic separation is achieved using Phenomenex C18 (75 x 4.6 mm, 2.6 μ, 100 Å) with mobile phase comprised of water: acetonitrile (30%:70% v/v). Valsartan shows a retention time of 2.71 min at 1 mL/min flow rate and the wavelength was detected at 247 nm. Robustness, specificity, precision, accuracy, linearity, LOD and LOQ was validated using this method. The LOD is 1.24 μg/mL and LOQ is 3.6 μg/mL. The calibration curve in the concentration range of 5-50 μg/mL is linear with coefficient of correlation 0.9999. The % recovery of the valsartan is in the range of 98.9%-102% and the % RSD is <2%. This method is successfully applied for quantitative determination of valsartan in tablet dosage form.