DEVELOPMENT AND VALIDATION OF AN RAPID RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF DRUG CEFIXIME AND ORNIDAZOLE IN TABLET DOSAGE FORM
An accurate, Precise, Simple and Economical High Performance Liquid Chromatographic method for the estimation of Cefixime and Ornidazole was developed and validated. The method so developed is Reverse Phase High Performance Liquid Chromatographic method using Hypersil ODS C-18 (150mm×4.6mm) with a Triethyl amine buffer adjusted with Ortho phosphoric acid (PH 5.5). Buffer and Acetonitrile were mixed in a proportion of 75:25 v/v as mobile phase. The method so developed was Validated in compliance with the National, Regional and International Regulatory Guidelines by Using very well developed Analytical Method Validation Tool which comprises with the analytical method validation parameters like Specificity, Forced degradation, System suitability, Method precision, Linearity, Accuracy, Range, Robustness, Ruggedness, Solution stability, Filter validation. The results obtained were well within the acceptance Criteria.