Simple Method Development and Validation of Valsartan in Bulk and Tablet Dosage Form

Abstract

A simple, economic UV spectroscopic method has been developed and validated for estimation of Valsartan in bulk and tablet dosage form. The λmax for Valsartan in methanol showed at 249 nm and in phosphate buffer pH 6.8 showed at 250 nm. Calibration plots were plotted over the concentration range 2 to 10 µg/ml with correlation coefficient 0.9991 in methanol and 10 to 50 µg/ml with correlation coefficient 0.9999 in phosphate buffer pH 6.8. Validation was performed as per ICH Q2 (R1) guidelines for linearity, accuracy, precision and robustness. The limit of detection for Valsartan in methanol and phosphate buffer pH 6.8 was found to be 0.47 µg/ml and 0.57 µg/ml and limit of quantification for Valsartan in methanol and phosphate buffer pH 6.8 was found to be 1.44 µg/ml and 1.75 µg/ml. The percent purity of Valsartan in tablet dosage form was 98.8%. Results of validation found to be significant acceptable limit. The developed UV spectroscopic method can be used for routine estimation of Valsartan in bulk and dosage form, using both water and phosphate buffer pH 6.8 as a solvent.