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Original Article

J App Pharm Sci. 2020; 10(2): 97-107


Development and validation of a stability indicating UHPLC method for Sacubitril/Valsartan complex in the presence of impurities and degradation products

Pintu Prajapati, Dhara Bhayani, Priti Mehta.




Abstract

Sacubitril/Valsartan (SAC/VAL) is a combination drug used for the treatment of heart failure. In the present work, novel and rapid, sensitive, specific and robust UHPLC method was developed and validated for the simultaneous estimation of SAC/VAL in presence of their seven related impurities and degradation products. The chromatographic separation was achieved on Accucore XL C8, (100 x 4.6) mm; 3 μm reverse phase column maintained at 30 °C. The peaks were eluted using tetrahydrofuran (THF) and 0.1% perchloric acid in water (8:92, %v/v) as a mobile phase A and THF: water: acetonitrile (5:15:80, %v/v/v) as mobile phase B in a gradient mode. The flow rate was set at 0.6 ml/min and the analytes were monitored in the range of 200-400 nm using a PDA detector for 21 min 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 and neutral hydrolytic as well as oxidative stress conditions. All the degradation products were separated from each other, SAC/VAL and their impurities showing the stability indicating power of the method. The newly developed method can be used for estimation of assay and related substances from bulk or their finished products with good efficiency.

Key words: UHPLC; Sacubitril/Valsartan; validation; forced degradation; method development; stability indicating






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