METHOD DEVELOPMENT AND VALIDATION OF VALSARTAN BY RP-HPLC

A simple, precise, accurate, and environmentally friendly RP-HPLC method was developed and validated for the determination of Valsartan in bulk and pharmaceutical formulations. Chromatographic separation was achieved using an Inertsil ODS C8 (100 × 4.6 mm, 5 µm) column with a mobile phase consisting of acetonitrile and potassium dihydrogen phosphate buffer (pH 6.1) in a 30:70 v/v ratio. The flow rate was maintained at 1.5 mL/min, detection was carried out at 247 nm, and the column temperature was kept at 27 °C. The retention time of Valsartan was found to be 4.705 min. The method showed excellent linearity (25–125 µg/mL) with a correlation coefficient of 0.9999, precision with %RSD below 0.5%, and recovery of 99.69%. The LOD and LOQ values were 1.468 µg/mL and 4.45 µg/mL, respectively. The method was validated as per ICH guidelines and successfully applied to commercial tablet dosage forms, proving its suitability for routine quality control analysis. KEY WORDS: Method development, RP-HPLC, Valsartan, Method validation.