European Journal of Biomedical and Pharmaceutical Sciences

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF SACUBITRIL AND VALSARTAN IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLC

Thushara B. S.*

ABSTRACT

A simple and selective LC method is described for the simultaneous estimation of sacubitril and valsartan in tablet dosage forms. Chromatographic separation was achieved on a Inertsil ODS 3V column using mobile phase consisting of a mixture of 55 volumes of Triethylamine buffer, and 45 volumes of acetonitrile; pH 3.5 at isocratic mode and eluents were monitored at 235 nm.With the optimized method, the retention times of sacubitril and valsartan were found to be 2.523 and 4.410mins respectively with theoretical plate count and assymetry as per the ICH limits. Linearity was observed in the concentration range of 5-15μg/ml for Sacubitril (r2 =0.999) and 2.5-7.5 μg /ml for Valsartan (r2 =0.999). The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. The percentage assays were found to be 100.27% and 101.98% respectively. Limit of detection and Limit of quantification values were found to be 0.015, 0.038 and 0.004, 0.011 respectively .All statistical data proves validity of the method in accordance with ICH guidelines and hence can be successfully applied to the simultaneous estimation of Sacubitril and Valsartan.

Keywords: Sacubitril, Valsartan, RP-HPLC, ICH Guidelines.