New Method Development and Validation for the Simultaneous Estimation of Sacubitril and Valsartan in Abulk and Pharmaceutical Dosage Forms

Abstract

A simple and selective LC method is described for the determination of Sacubitril and Valsartan in tablet dosage forms. Chromatographic separation was achieved on a c₁₈ column using mobile phase consisting of a mixture of 80 volumes of methanol and 20 volumes of water with detection of 241 nm. Linearity was observed in the range 60-140µg /ml for Sacubitril (r² =0.997) and 61-155µg /ml for Valsartan (r² =0.997) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim.

                The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.