title: Comparison of high-pressure liquid chromatography and microbiological assay for determination of ciprofloxacin tablets in human plasma employed in bioequivalence and pharmacokinetics study.
abstract: Ciprofloxacin was given orally to 28 healthy male volunteers for single oral dose of 500mg; Plasma samples were collected at different time's interval between 0 and 12h and analyzed both by high pressure liquid chromatography and by a microbiological assay. The detection limits (LOD) were 0.02μg/ml and 0.1μg/ml, for both methods respectively. For each method, coefficients of variation (R(2)) were 0.9995 and 0.9918 in plasma and limit of quantitation (LOQ).02 and 0.5μg/ml. The Comparison of  means maximum concentration 2.68 μg/ml at 1.5 hr for test and 2.43 μg/ml are attain in HPLC method of Reference at 2hrs respectively. The plasma concentrations measured by microbiological assay of reference tablet are 3.95μg/ml (mean ± SE) at 1 hour and 3.80μg/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-oo) 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-oo) 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.
authors.affiliation: Gomal University, Dera Ismail Khan, Pakistan. khalidryu57@hotmail.com
authors.forename: Muhammad Khalid
authors.initials: MK
authors.lastname: Khan
authors.forename: Muhammad Farid
authors.initials: MF
authors.lastname: Khan
authors.forename: Ghulam
authors.initials: G
authors.lastname: Mustafa
authors.forename: Mohammed
authors.initials: M
authors.lastname: Sualah
mesh_terms: D000328:Adult; D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000706:statistics & numerical data*; D002939:Ciprofloxacin / Q000097:blood* / Q000493:pharmacokinetics*; D052978:Disk Diffusion Antimicrobial Tests / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D013607:Tablets / Q000493:pharmacokinetics; D013810:Therapeutic Equivalency
chemical_list: D013607:Tablets; D002939:Ciprofloxacin