Development and Validation of UV Spectroscopic Method for Estimation of Valsartan In Tablet Dosage Form

To develop and validate simple, rapid, linear, accurate, precise and economical UV Spectroscopic method for estimation of Valsartan in tablet dosage form. The drug is freely soluble in analytical grade Ethanol, Methanol and Acetonitrile. The drug was identified in terms of solubility studies and on the basis of melting point done on Melting Point Apparatus of Equiptronics. It showed absorption maxima were determined in diluent Methanol: Water (50:50) ratio. The drug obeyed the Beer’s law and showed good correlation of concentration with absorption which reflect in linearity. The UV spectroscopic method was developed for estimation of Valsartan in tablet dosage form and also validated as per ICH guidelines. The drug is freely soluble in analytical grade Ethanol, Methanol, Acetonitrile and sparingly soluble in water. So, the analytical grade Methanol: water (50:50) is used as a diluent in method. The melting point of Valsartan was found to be 115-116?C (uncorrected). It showed absorption maxima 250 nm in Methanol: Water (50:50) ratio. On the basis of absorption spectrum the working concentration was set on 20µg/ml (PPM). The linearity was observed between 10-30 μg/ml (PPM). The results of analysis were validated by recovery studies. The recovery was found to be 98.75, 101.00 and 99.17% for three levels respectively. The % RSD for precision was found to be 0.35%. A simple, rapid, linear, accurate, precise and economical UV Spectroscopic method has been developed for estimation of Valsartan in tablet dosage form. The method could be considered for the determination of Valsartan in quality control laboratories. Keywords: Valsartan, Development, UV Spectrophotometer, Melting Point, Assay Method, Validation, Accuracy, Linearity, Ruggedness, Precision.