Varsha Chandgude, G. K. Dyade, R. B. Jadhav
Abstract: Stability indicating validated RP-HPLC method was developed for simultaneous estimation of Benidipine Hydrochloride (BPH) and Telmisartan (TEL) from combined dosage form. The separation of drugs was achieved on a Phenomenax C18 Column (2504.6 mm, 5m particle size) with UV detection 237 nm using a mobile phase consisting of Methanol: Acetonitrile: water in the ratio of 70: 20: 10 v/v at a flow rate 0.8ml/min. Retention time was found as 2.51 min for BPH and 3.227 min for TEL.Both drugs obey Beers law in the range of 2-10 g/ml for BPH and 5-25 g /ml for TEL. The proposed method was validated as per ICH guidelines for linearity, range, precision, accuracy, robustness and LOD, LOQ and stress degradation studies were carried out under acidic, alkaline, photolytic, thermal degradation condition as per SIAM as described by ICH guidelines. The method is accurate, precise and rapid for routine analysis of BPHand TEL from dosage form. Stress degradation studies proved methods rigidity.
Keywords: Benidipine Hydrochloride BPH, TEL TEL, RP-HPLC, Validation, Stabilitystudies