Online ISSN: 2515-8260

Development of Stability indicating method for the estimation of Ornidazole in Pharmaceutical Formulations

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Archana Naik, Purnima Hamrapurkar, Arvind Naik, Bhaskar Gavitre, Nitin Kolhe

Abstract

For the determination of ornidazole (ONZ) in tablet dosage forms, a simple, specific, accurate, stability-indicating reverse phase liquid chromatographic method was developed.. A stationary phase used was Waters Spherisorb RP-C18, 5 m column having 250 x 4.6 mm, with a mobile phase containing 20 mM Ammonium Acetate(pH 4.0 with Acetic Acid): acetonitrile (70:30 % v/v) at a flow rate of 1ml/min in isocratic mode. The retention time of ornidazole was 6.8 min. The linearity for ornidazole was in the range of 0.050 – 15 g/ml. The accuracy of the optimized HPLC method by recovery was found to be in the range of 99.12 – 100.54 %w/w. The detection limit and quantification limit were found to be 0.015 g/ml and 0.050 g/ml, respectively. Stress studies were conducted on drugs under ICH ICH-prescribed conditions, viz, hydrolysis, oxidation, photolysis and thermal stress. Ornidazole was exposed to acid, alkali, Neutral, 3% H2O2, accelerated temperature and Photolysis. Stress conditions indicate that the drug is susceptible to strong acid, base hydrolysis, oxidative hydrolysis, photolysis in acidic conditions and dry heat degradation. The pure drug peak and the degraded product peaks were clearly separated, and their retention time values varied significantly. The proposed method for the determination of ornidazole in tablet formulations has been validated and successfully applied

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