Abstract

ANALYTICAL METHOD VALIDATION AND QUANTIFICATION OF AZILSARTAN KAMEDOXOMIL DRUG SUBSTANCE AND ITS RELATED SUBSTANCES BY USING REVERSE PHASE - LIQUID CHROMATOGRAPHIC METHOD

Yenisetty Ranganayakulu*, Korupolu Raghu Babu and Dr. Raja Gorla

Abstract

An efficient and selective RP-HPLC method was developed and validated for the determination of process and degradation impurities in Azilsartan kamedoxomil (AKM) drug substances which were identified and characterized by LCMS, FTIR, 1H NMR, C NMR techniques. Chromatographic separation was achieved on Sunfire C18, (250 mm x 4.6 mm, 5 μm) column thermostated at 20°C under gradient elution by a binary mixture of potassium dihydrogen orthophosphate (pH-3.0) and ACN at a flow rate of 1.0 ml/min. A photodiode array (PDA) detector set at 254 nm was used for detection. Stress testing (forced degradation) was carried out under acidic, alkaline, oxidative, photolytic, thermal and humidity conditions. AKM drug substance is susceptible to degrade under acid, alkaline, oxidative hydrolysis and humidity stress condition. The developed method is validated with respect to sensitivity (LOD and LOQ), linearity, precision, accuracy, and robustness, and can be implemented for routine quality control analysis and stability testing of AKM.

Keywords: Azilsartan medoxomil, Stability indicating, Method development and Validation, Degradation impurities.