A Validated RP-HPLC Method Development and Validation for Sacubitril and Valsartan in Combine Pharmaceutical Dosage Forms

Sarada¹, P. Sowjanya², Dr. Gampa Vijaya Kumar*^3
1,2KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India.
³Professor and Head, Dept. of Pharmacy, KGR Institute of Technology and Management, Rampally, Kesara, Rangareddy, Telangana, India

A B S T R A C T
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 Terrosil 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 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 was found in range of 0.2µg-0.6µg and 0.1µg-0.3µg and correlation coefficient was found to be 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 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.
Keywords: Valsartan, Sacubitril, RP-HPLC, Method development, Validation.