Development and validation of RP-HPLC method for the simultaneous estimation of Valsartan and Sacubitril in pharmaceutical dosage form

Abstract

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 Pharmaceutical dosage form. Chromatographic separation trials were done using three columns and four mobile phases in different ratios. Columns used are Thermosil C₁₈ column(100mm×4.6mm)5µm, Xterra C₁₈ column(150mm×4.6mm)5µm and Chromosil C₁₈ column having dimension of (150mm x 4.6 mm)5µm and mobile phase used are water, methanol, acetonitrile, phosphate buffer in different logic ratios based on polarity, 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 1ml/min and detection wavelength at 254nm. The retention times of Valsartan and Sacubitril was found to be 2.589 and 3.711mins. The proposed method has been validated for accuracy, precision, linearity, robustness and range were within the acceptance limit according to ICH guidelines. Linearity for Valsartan and Sacubitril were found in range of 0.2µg-0.6µg and 0.1µg-0.3µg and correlation coefficient were found to be 0.999 and 0.999 respectively. %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 99.77% to 100.12% respectively. The method was found to be robust even by change in the mobile phase ±5% and in less flow condition. The developed method can be successfully employed for the routine analysis of Valsartan and Sacubitril in API and Pharmaceutical dosage forms.