SIMPLE HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHIC METHOD TO ANALYZE MEGAZOL IN HUMAN AND RAT PLASMA

A simple and sensitive high-performance liquid chromatographic method has been developed to measure megazol in human plasma. The method was optimized and validated according to the Washington Concensus Conferen ce on the Validation of Analytical Methods (V.P. Shah et al., Eur. J. Drug Metab. Pharmacokinet., 15 (1991) 249). The criteria of complete v alidation were specificity, linearity, precision, analytical recovery, dilution and stability. It involved extraction of the plasma with dic hloromethane, followed by reversed-phase high-performance liquid chrom atography using a Kromasil(R) C-8 column and UV detection at 360 nm. T he retention times of the internal standard (tinidazol) and megazol we re 6.10 and 9.60 min, respectively. The standard curve was linear from 2 ng ml(-1) (limit of quantification) to 2000 ng ml(-1), The coeffici ents of variation for all the criteria of validation were less than 6% ; 85 to 92% extraction efficiencies were obtained. Megazol was stable during the storage period (one month at -20 degrees C) in plasma and f or two months at 25 degrees C in standard solution. The method was tes ted by measuring the plasma concentration following oral administratio n to rat and was shown to be suitable for pharmacokinetic studies. (C) 1997 Elsevier Science B.V.