Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SACUBITRIL AND VALSARTAN IN BULK AND PHARMACEUTICAL DOSAGE FORM

Arti M. Jadhav* and Hemlata S. Bhawar

Abstract

A simple, precise and reproducible Reverse Phase High Performance Liquid Chromatography method was developed and validated for simultaneous estimation of Sacubitril and Valsartan in tablet dosage form. Chromatographic separation was achieved by Grace C18 (250 mm x 4.6 ID, Particle size- 5 micron) column and methanol: water (90:10v/v) as mobile phase, at a flow rate of 1 ml/min (millilitre per minute) using UV detection at 244nm. Forced degradation experiments were carried out by exposing Sacubitril and Valsartan standard and sample for thermal, photolytic, oxidative and acid-base hydrolytic stress conditions. The retention time for Sacubitril and Valsartan were obtained as 6.984min and 5.311 min. respectively. The method has been validated for linearity, accuracy, precision, LOD, and LOQ. Linearity of Sacubitril and Valsartan were found to be 12-60μg/ml.(R2=0.9987) and 13-65μg/ml.(R2=0.9979) respectively. The accuracy of present method was evaluated at 50%, 100%, 150%. Recovery was found to be in a range from 99.13%-101.25% for sacubitril and 98.92%-101.80% for valsartan. Intermediate precision studies were carried out and the RSD values were less than 2%. Lower values of LOD (0.096μg/ml) and LOQ (0.293μg/ml) for sacubitril and LOD (0.280μg/ml) and LOQ (0.849μg/ml) for valsartan indicated good sensitivity of the method. In this study, the optimization of mobile phase, flow rate, injection volume and wavelength were achieved. This demonstrate that the developed method is simple, precise, accurate and robust for simultaneous estimation of Sacubitril and Valsartan in tablet dosage form. The method was acceptable for degradation studies of heat, sunlight, acid, base, peroxide which meet the acceptance criteria for forced degradation studies.

Keywords: Sacubitril, Valsartan, RP-HPLC, Validation.