Stability indicating RP-HPLC Method for Simultaneous estimation of Valsartan and Sacubitril in Pharmaceutical Dosage Form

Sacubitril/Valsartan (SAC/VAL) is a combination drug used for the treatment of heart failure. In the present work, rapid, sensitive, specific, and robust high-performance liquid chromatography method was developed and validated for the simultaneous estimation of SAC/VAL in pharmaceutical dosage form. The chromatographic separation was achieved on Zorbax SB C8, (150 × 4.6 mm, 5 μm) column. The peaks were eluted using 0.02 M ammonium acetate buffer: acetonitrile (55:45, %v/v) (pH-3.0 adjusted with glacial acetic acid) as mobile phase. The flow rate was set at 1.0 ml/minute and the analytes were monitored in the range of 200–400 nm using a Photo Diode Array (PDA) detector for 10 minutes run time. The method was validated as per ICH Q2 (R1) guideline and all the validation parameters were found within the acceptance criteria. The forced degradation study for SAC/VAL showed that the drugs were prone to acidic, alkaline, oxidative stress conditions. All the degradation products were separated from each other, SAC/VAL and their degradation products showing the stability indicating criteria of the method. The developed method can be used for estimation of assay from bulk or their finished products with good efficiency.