Analytical Method Development and Validation for the Estimation of Sacubitril and Valsartan in Combined Pharmaceutical Dosage Forms by RP-HPLC
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The Present work was to develop a simple, fast, accurate, precise, reproducible, Reverse Phase High Performance Liquid Chromatographic Method for simultaneous estimation of Valsartan and Sacubitril in pure drug form. Chromatographic separation was done using thermosil C18 column having dimension of (100 mm x 4.6 mm) having particle size of 5.0 μm, with mobile phase consisting of Phosphate buffer (KH2PO4 and K2HPO4) pH 3 ±0.02 pH adjusted with ortho phosphoric acid and Acetonitrile (25: 75%v/v), flow rate was adjusted to 0.8 ml/min and detection wavelength at 254nm. The retention times of Valsartan and Sacubitril was found to be 2.589 and 3.711mins. The method has been validated for accuracy, precision, linearity, robustness and range. Linearity for Valsartan and Sacubitril was found 0.2μg-0.6μg and 0.1μg-0.3μg and correlation coefficient was 0.999 and 0.999% RSD for intermediate precision was found to be 0.1 and 0.2, for repeatability was 0.2 and 0.5, % mean recovery for Valsartan and Sacubitril was found to be 100.599% to 101.22% respectively. The method was found to be robust even by change in the mobile phase ±5% and in less flow condition.
Valsartan, Sacubitril, RP-HPLC, Accuracy, Precision, Linearity, Robustness, Range.