Method Development and Validation of Valsartan by Using Stability-Indicating RP-HPLC Method

This study had the objective to establish and validate a reverse-phase high -performance liquid chromatography (RP-HPLC) technique for the quantification of valsartan in its formulations, serving as an indicator of stability. The selected HPLC system employed a UV -07368 column (Instrument ID: QCL-HPL-022), specifically the SHIMADZU LC2010C HT. A novel mobile phase was developed using a volumetric ratio of acetonitrile, water, and glacial acetic acid at 50:50:0.1 (V/V/V), with a flow rate set at 1 ml/min. Detection was carried out at 230 nm. Valsartan underwent stress testing, including UV deterioration, thermal degradation, and hydrolytic degradation in alkaline, acidic, along with neutral circumstances to evaluate the stability-indicating properties of the technique. The method exhibited a linear correlation over a concentration range of 80-240 ppm (r(2) = 0.999), described by the regression equation y = 21.80x - 188.2. Valsartan demonstrated noteworthy stability under conditions of heat, oxidative stress, acidity, base, and neutrality. The procedure underwent validation for robustness, linearity, specificity, accuracy, and precision. The findings suggested that the method is swift, accurate, precise, reproducible, and dependable, rendering it suitable for analyzing commercial dosage forms in accordance with ICH recommendations.