STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT, VALIDATION AND DETERMINATION OF RESIDUAL COMPONENTS OF CEFIXIME IN PHARAMACEUTICAL DOSAGE FORM
Chandana Mannepalli*, Prasadarao Manchineni, A. R. M Sai, A. Gopi, K. Umadevi, M. Dharani and M. Padmavathi
ABSTRACT
A simple rapid and precise Rp-hplc method for cefixime in a pharmaceutical solid dosage form has been developed and validated. Chromatography was performed on a 150mm x 3.9mm i.d 4μparticle C18 Column with Tetra butyl ammonium hydroxide and Aceto nitrile 77:23(v\v) PH-7 adjusted with phosphate buffer as mobile phase at a flow rate of 1ml\min. UV detection was performed at 254nm.Run time 20 min; cefixime retension time is 9.010.The method was validated for accuracy, precision, linearity, LOD, LOQ, Robustness, Ruggedness, specificity, and sensitivity in accordance with ICH guide lines. Validation revealed the method is specific, rapid, accurate, precise, reliable and reproducible. Calibration plot was linear over the concentration ranges 20μg/ ml for cefixime. Limit of detection is 0.14μg/ml and limit of quantification is 2 μg/ml for cefixime. The high recovery and low coefficients of variation confirm the suitability of the method for cefixime drug in tablets. The validated method was successfully used for quantitative analysis of cefixime tablets. Find out the impurities of given cifixime by using the validated method with help of HPLC. Estimate the amount of residual solvents by Gas chromatography.
Keywords: RP-HPLC, GC, Validation, Residual Solvents, Impurities, Cefixime.
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