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Abstract

FORCED DEGRADATION OF SACUBITRIL AND VALSARTAN: DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD

Murugan S.* and Vetrichelvan T.

ABSTRACT

In the present work, a new validated stability indicating HPLC method for quantitative determination of Sacubitril (SAC) and Valsartan (VAL) in tablet formulation was developed. The column was Phenomenex Luna C18 column (150 mm × 4.6 mm id; 5μm particle size) and the mobile phase was composed of Acetonitrile: Water in 0.1% of Trifluoroacetic acid (50:50,v/v) with a flow rate 1 ml/min. Eluents were monitored by UV detector at 242 nm. Calibration curve was linear in the concentration ranges 4.9–24.5μg/ml (R2 value is 0.9997) for SAC and 5.1 – 25.5μg/ml (R2 value is 0.9998) for VAL. SAC and VAL were subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. The developed method was found to give good separation between pure drug and degraded products. The proposed method was successfully applied for the stability assay of SAC and VAL in tablet formulation and validated as per ICH guidelines.

Keywords: Sacubitril, Valsartan, HPLC Method, Forced degradation studies.


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