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A Liquid Chromatography��?Mass Spectrometry/Mass Spectrometry Method for the Quantification of Cefixime in Human Plasma

R Arunkumar, A Olaganthan, Nageswara Rao, V Sankar, and S Gunasakaran

Cefixime is a third generation cephalosporin effective against gram-positive and gram-negative organisms. It is available in solid and liquid oral dosages of 100 mg, 200 mg and 400 mg. It is used to treat respiratory and urinary tract infections. In this study, a liquid chromatography-Mass spectrometric method to quantify cefixime in human plasma was developed. The quantification range for the method was 114.5033 to 9374.2050 ng/ml and the method was validated as per US FDA standards for pharmaceutical development. Cephalexin was used as the internal standard. Chromatographic and mass spectrometric conditions and extraction procedures were optimized to quantify the levels of cefixime in human plasma accurately. 100 μL of K3EDTA human plasma was required for sample processing. Extraction of cefixime and cephalexin was done by Liquid-Liquid extraction and separation was achieved by reverse phase liquid chromatography. Specificity, selectivity, matrix effect, calibration curve, precision, accuracy, ruggedness, recovery, stability and dilution integrity were established for cefixime in human plasma. The method met acceptance criteria for all the validation parameters and can be successfully applied to human pharmacokinetic and bioequivalence studies of cefixime. The bioanalytical method was highly sensitive and selective for estimation of cefixime in human plasma samples containing the drug