Abstract

DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF VALSARTAN AND SACUBITRIL IN TABLET DOSAGE FORM.

M. Madan Mohan Reddy*, D. Gowri Sankar and JVLN Seshagiri Rao

ABSTRACT

Objective: A New method was established for simultaneous estimation of Sacubitril And Valsartan by RP-HPLC method. Methods: Chromatographic separations were carried using Spurcil C18 (4.6 x 250mm, 5m) (Dikma column) column with a mobile phase composition of 0.1% OPA buffer and Acetonitrile(50:50) have been delivered at a flow rate of 1ml/min and the detection was carried out using waters HPLC auto sampler, separation module 2695 with PDA detector at wavelength 237 nm. Results: The retention time for Sacubitril and Valsartan were 3.119 and 6.851 minute respectively. The correlation coefficient values in linearity were found to be 0.999 and concentration range 12-60 μg/ml for Sacubitril and 13-65μg/ml for Valsartan respectively. For accuracy the total recovery was found to be 99.98% and 100.28% for Sacubitril and Valsartan. The LOD and LOQ concentration for Sacubitril were found to be 0.02 μg/ml and 0.05 μg/ml and LOD and LOQ for Valsartan were found to be 0.01μg/ml and 0.04 μg/ml. The force degradation studies were performed and the results are within the limits. Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Sacubitril and Valsartan in pharmaceutical dosage form.

Keywords: Sacubitril, Valsartan, RP?HPLC, Validation.