DEVELOPMENT OF ASSAY METHOD AND FORCED DEGRADATION STUDY OF VALSARTAN AND SACUBITRIL BY RP-HPLC IN TABLET FORMULATION

Objective: A stability-indicating high performance liquid chromatographic (HPLC) method was developed and validated for the estimation of combined tablet formulation of valsartan and sacubitril.Methods: Chromatographic separation was optimized by gradient HPLC on a C18 column [Xterra, 250 x 4.6 mm, 5µ] utilizing a mobile phase consisting acetonitrile, methanol and potassium dihydrogen phosphate, pH 3.8 in the ratio of 30: 50:20 v/v at a flow rate of 1 ml/min with UV detection at 263 nm.Results: The retention time of sacubitril and valsartan was 3.01 min and 4.22 min respectively. Good linearity obtained over the range of 20μg/ml to 160μg/ml for valsartan and sacubitril. The correlation coefficient was found to be 0.999and0.998 for sacubitril and valsartan respectively. The % RSD of precision for sacubitril and valsartan was found to be 0.31 and 0.27 respectively. The % mean recovery was found to be 99.20-99.54% for valsartan and 99.85-100.90% for sacubitril. The results obtained for accuracy, precision, LOD, LOQ and ruggedness were within limits.Conclusion: The proposed HPLC method was found to be simple, specific, precise, accurate, rapid and economical for simultaneous estimation of valsartan and sacubitril in bulk and tablet dosage form. Thus the validated economical method was applied for forced degradation study of valsartan and sacubitril tablet.