Volume :
2
Issue :
1
Abstract :
A new simple, rapid, specific, accurate and precise stability indicating RP-HPLC method has been developed for the estimation of Sacubitril and Valsartan in bulk & pharmaceutical dosage form. From UV spectrophotometric method selected wavelength for estimation of drugs were 241 nm as isobestic point and 230 nm, 228 nm as λ max of SAC and VAL respectively by using methanol as a solvent. RP-HPLC method was developed by using Inertsil ODS (250×4.6mm) 5µ. The samples were analyzed by using mixed phosphate buffer (PH adjusted to 3 using orthophosphoric acid): Methanol: Acetonitrile (30:50:20 % v/v) as the mobile phase at the flow rate of 1.0 ml/min and detection wavelength is 241 nm. Both the drugs were eluted within 5 minutes and gave sharp peaks with high theoretical plate count and low tailing factor. The retention time for Sacubitril and Valsartan was found to be 2.927min and 4.003 min respectively. Calibration curve was linear with correlation coefficient of 0.997 and 0.997 over a concentration range of 58.8-137.2 µg/ml and 61.2-142 µg/ml for Sacubitril and Valsartan respectively. The percent recovery was 99.60and 98.08for Sacubitril and Valsartan respectively indicating accuracy and reliability of the method. Forced degradation studies were carried out and drug peaks were well resolved without any significant degradation products when subjected to stress conditions. So the developed stability indicating method could be utilized for routine analysis of Sacubitril andValsartan in bulk and pharmaceutical dosage form.