Assessment of bioequivalence of ciprofloxacin in healthy male subjects using HPLC.

Author(s): Khan MK, Khan MF

Affiliation(s): Faculty of Pharmacy Gomal University, Dera Ismail Khan, Pakistan.

Publication date & source: 2008-07, Pak J Pharm Sci., 21(3):299-306.

Publication type: Randomized Controlled Trial

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.