ABSTRACT: The development and validation for the simultaneous estimation of Sacubitril and Valsartan achieved by X-Terra RP-18 (150mm*4.6mm, 5µm) column, with a mobile phase of 0.1% formic acid in water and Methanol (25:75% v/at a flow rate of 0.8ml/min at ambient temperature. The peaks were observed by a UV-detector at 267nm and the retention time for both the drugs was 3.156 and 2.663min. The percentage recovery was 99-100% for both the drugs. Method validation was carried out for all above new methods developed. Linearity parameter for the method was analyzed by preparing solution of five levels of concentrations. Calibration curve for concentration versus peak areas was found linear. Precision was studied by preparing solutions in six replicates and analyzed, % RSD was calculated for the peak areas of each drug. Accuracy for new methods developed, evaluated by using the standard solutions of three different concentrations (50%, 100% and 150%) into sample solution and their percentage recovery at each level was determined. Robustness for above methods was carried out at different flow rates and at different organic composition, standard and sample solutions were prepared and analyzed at + 0.1ml/min and at + 10% and developed method found to be stable on deliberate variation. Parameters evaluated for validating novel RP-HPLC methods for simultaneous determination of above dosage forms meet the requirements of ICH guidelines. The developed methods are simple, precise, cost effective and rapid. These newly developed methods can be applied for the quantitative determination in the QC laboratories for the regular release.
AMPATI SRINIVAS, K.MAMATHA, Dr. AMPATI SRINIVAS
Sacubitril; Valsartan; RP-HPLC; Method development; Validation
