Validated stability-indicating HPLC method for simultaneous estimation of ofloxacin and satranidazole from pharmaceutical dosage form.

ABSTRACT

The present paper describes development of stability- indicating RP- HPLC method for the simultaneous determination of Ofloxacin and Satranidazole in presence of its degradation products, generated from forced degradation studies. Ofloxacin and Satranidazole and their combination drug product were exposed to acid, base, neutral hydrolysis; oxidation, dry heat, photolytic stress conditions and the stressed samples were analyzed by proposed method. The proposed HPLC method utilizes HiQ sil C18W column (250mm × 4.6mm i.d., 5μm) of KYA TECH, Corporation and a mobile phase comprising of acetonitrile phosphate buffer (pH3) in ratio of 3565v/v with flow rate of 1ml/min. The retention time of OFLX and STZ was found to be 2.85min and 6.25min respectively. Quantitation was achieved with UV detection at 296nm for OFLX and 320nm for STZ. The method has been validated for ofloxacin and satranidazole in terms of accuracy, precision, linearity, LOD, LOQ and robustness. The developed validated stability-indicating HPLC method was found to be simple, specific, accurate and reproducible for the determination of instability of these drugs in bulk and commercial products.