Assessment of bioequivalence of ciprofloxacin in healthy male subjects using HPLC.
Pharmacokinetics and bioequivalence studies of two brands of ciprofloxacin 500 mg (Ciprofloxacin & Ciproxin) were evaluated in 14 healthy male volunteers after oral administration. The drug was analyzed in plasma samples by using HPLC. The peak plasma concentrations of (2.28+/-0.04 mg/L) and (1.9+/-0.02 mg/L) was attained in about 1.71 hours and 2.00 hours for both Test and Reference ciprofloxacin, respectively. The mean +/- SE values for total area under the curve (AUC) were 11.91+/-0.26 and 13.11+/-0.27 h.mg/L for both test and reference tablets respectively. This study indicated that all the differences in bioequivalence parameters for both ciprofloxacin formulations are statistically non-significant, hence both formulations are bioequivalent.
Khan
Muhammad Khalid
MK
Faculty of Pharmacy Gomal University, Dera Ismail Khan, Pakistan.
Khan
Muhammad Farid
MF
D000284:Administration, Oral; D000328:Adult; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000097:blood / Q000494:pharmacology*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D018592:Cross-Over Studies; D006801:Humans; D008297:Male; D013607:Tablets; D013810:Therapeutic Equivalency
D000890:Anti-Infective Agents; D013607:Tablets; D002939:Ciprofloxacin