Abstract

STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SACUBITRIL AND VALSARTAN IN BULK AND COMBINED PHARMACEUTICAL DOSAGE FORM

Muqhtar Ahmed*, A. Satishkumar Shetty, Manzoor Ahmed, Vijaya Krishna C. Aradhya, Anil Kumar S. M. and Siddalinga Swamy M. S.

ABSTRACT

A Stability indicating RP-HPLC method was developed and validated using Enable C18 250 x 4.6 mm, 5 μm column with mobile phase composition of Acetonitrile and Citrate buffer (pH 3) in the ratio of 60:40 v/v, flow rate of 1.0 mL/min and UV detection at 267.0 nm, linearity was observed over concentration range of 20-320 μg/mL for both Sacubitril and Valsartan. The accuracy of the proposed method was determined by recovery studies and found to be 99.92 to 100.09% and 99.92 to 100.06% for Sacubitril and Valsartan respectively. The proposed method was extended for estimation of Sacubitril and Valsartan in marketed tablet formulation and assay values conformed to the label claim of the marketed tablet formulation followed by subjecting the drug to hydrolysis, oxidation, photolysis and thermal degradation studies. The drug was found to degrade extensively in acidic 0.1 N HCl 86.96 & 86.31 for SAC & VAL and in alkaline medium 0.1 N NaOH 66.65 & 99.05 for SAC & VAL. Mild degradation was observed, when exposed to oxidation, thermal condition and UV studies. This developed and validated Stability indicating HPLC method can be used for routine analysis of Sacubitril and Valsartan in tablets.

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