Abstract
DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SACUBITRIL AND VALSARTAN IN DRUG PRODUCT BY RP-HPLC

Benzil Dudekula, Dr. C. Ramachandraiah and Dr. N. Devanna*

ABSTRACT

New Analytical method was developed for the estimation of Valsartan and Sacubitril in drug product by liquid chromatography. The chromatographic separation was achieved on C18 column (Xterra RP18 150*4.6mm) at ambient temperature. The separation achieved employing a mobile phase consists of 0.1%v/v Formic acid in water: Methanol(25:75). The flow rate was 1.0ml/ minute and ultra violet detector at 267nm. The average retention time for Valsartan and Sacubitil found to be 2.66 min and 3.154 min. the proposed method was validated for selectivity, precision, linearity and accuracy. All validation parameters were within the acceptable range. The assay methods were found to be linear from 51.5 - 154.5μg/ml for Valsartan and 48.5 -145.5μg/ml of Sacubitril.

Keywords: Valsartan and Sacubitril, Isocratic, HPLC, Xterra RP18, Formic acid, Acetonitrile, Methanol and validation.


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