Muhammad Khalid Khan, Muhammad Farid Khan, Ghulam Mustafa, Mohammed Sualah.
Comparison of high-pressure liquid chromatography and microbiological assay for determination of ciprofloxacin tablets in human plasma employed in bioequivalence and pharmacokinetics study.
Pak J Pharm Sci Jan ;25(1):81-8.
Ciprofloxacin was given orally to 28 healthy male volunteers for single oral dose of 500mg; Plasma samples were collected at different timefs interval between 0 and 12h and analyzed both by high pressure liquid chromatography and by a microbiological assay. The detection limits (LOD) were 0.02ug/ml and 0.1ug/ml, for both methods respectively. For each method, coefficients of variation (R2) were 0.9995 and 0.9918 in plasma and limit of quantitation (LOQ).02 and 0.5ug/ml. The Comparison of means maximum concentration 2.68 ug/ml at 1.5 hr for test and 2.43 ug/ml are attain in HPLC method of Reference at 2hrs respectively. The plasma concentrations measured by microbiological assay of reference tablet are 3.95ƒÊg/ml (mean } SE) at 1 hour and 3.80ƒÊg/ml (mean } SE) at 1 hour. The concentrations in plasma measured by microbiological method were markedly higher than the high-pressure liquid chromatography values which indicates the presence of antimicrobially active metabolites. The mean } SE values of pharmacokinetic parameters calculated by HPLC method, for total area under the curve (AUC 0-‡) were 13.11, and 11.91 h.mg/l for both test and reference tablets respectively. The mean } SE values of clearance measured in l/h were 44.91 and 48.42 respectively. The elimination rate constant Kel [l/h] showed 0.17 l/h for test and 0.15 l/h reference tablets and likewise, absorption half-life expressed in hours shown 0.67 h for test and 1.04 h for reference respectively. The Mean Residence Time for test is 5.48 h and 5.49 h for reference. The mean } SE values of pharmacokinetic parameters (Microbiological assay) for total area under the curve (AUC 0-‡) were 22.11 and 19.33 h.mg/l for both test and reference tablets respectively. The mean } SE values of clearance measured in l/h were 29.02 and 31.63 respectively. The elimination rate constant Kel [l/h] showed 0.21 l/h for test and 0.20 l/h reference tablets and likewise, absorption half-life expressed in hours shown 0.86h for test and 0.56 h for reference respectively. The Mean Residence Time for test is 5.27 h and 4.67 h for reference. Significant difference observed between two methods.
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