DEVELOPMENT AND VALIDATION OF A HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR DETERMINATION OF CEFIXIME TRIHYDRATE AND ITS DEGRADED PRODUCTS FORMED UNDER STRESS CONDITION OF UV LIGHTAbstract
A simple, accurate, precise and sensitive reverse phase high performance liquid chromatography (RP-HPLC) method for the determination of cefixime trihydrate and its degraded products have been developed and validated. Drug was resolved on a C18 column (waters spherisorb 25 cm × 4.6 mm, 5µm), utilizing mobile phase of sodium dihydrogen phosphate monohydrate (0.1M aqueous) pH adjusted to 2.5 with diluted orthophospharic acid (10 % aqueous) and methanol in a ratio of 3:1 respectively. Mobile phase was delivered at the flow rate of 1.0 ml/min. Ultra violet detection was carried out at 254 nm. Separation was completed within 9.75 minutes. Calibration curve was linear with correlation coefficient (r2) = 0.9996 over a concentration range 10-50µg/ml. Recovery was between 98.84, 100.25 percentage. Method was found to be reproducible with relative standard deviation (RSD) for intra and interday precision of < 1.0 over the said concentration range. The method was successfully applied to the determination of the decomposed products of cefixime trihydrate, it can be very useful and an alternate to performing the stability studies.
Elsadig H. K. Adam , Ahmed E. M. Saeed* and Izzeldin E. Barakat
Department of Chemistry, Collage of Science, Sudan University of Science and Technology
25 September, 2011
18 December, 2011
29 January, 2011