A STUDY OF METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION FOR SIMULTANEOUS QUANTIFICATION OF POVIDONE IODINE AND ORNIDAZOLE IN BULK AND PHARMACEUTICAL DOSAGE FORM BY USING RP-HPLCAbstract
An accurate, rapid economical, and simple, reliable assay method was developed and validated for the simultaneous estimation of Povidone-iodine and Ornidazole using RP-HPLC. In the proposed method, the efficient chromatographic separation was achieved using waters X-Bridge C8 column (150 × 2.1mm, 3.5µ) as a stationary phase and acetonitrile: 0.1% Orthophosphoric acid (50:50 v/v) as a mobile phase with a flow rate of 1 ml/min and UV detection was carried at 320nm. Chromatography was carried out isocratically at ambient temperature and the run time was 8 min. System suitability parameters were studied by injecting the standard six times, and results were well under the acceptance criteria. Linearity study was carried out between 10-150% levels, R2 value was found to be as 0.999. The precision of intermediate precision and method precision was found to be within the acceptable limit. By using the above method, assay of the marketed formulation was carried out and found to be within the limit. All the validation parameters as per ICH guidelines. Degradation studies of Povidone-iodine and Ornidazole were done; in all conditions purity threshold was more than purity angle and within the acceptable range.