A New HPLC Method for Determination of Ciprofloxacin in Human Plasma and its Application in Bioequivalence Studies

N. Adib¹ and Et Al²,

¹Food and Drug Laboratory Research Center, Food and Drug Control Labs, Ministry of Heath, Tehran Iran

²Department of Medicinal Chemistry, School of Pharmacy, Shaheed Beheshti Medical University, Tehran Iran.

Corresponding Author E-mail: nadib@fdo.ir

ABSTRACT: A simple, rapid and sensitive isocratic reversed-phase HPLC method with UV detection is described based on external-standard calibration for determination of ciprofloxacin in plasma samples during bioequivalence studies. Both internal and external procedures were evaluated and the external-standard method demonstrated a high validity based on ICH criteria. After protein precipitation with acetonitrile and dichloromethane, chromatographic analysis of ciprofloxacin in plasma was carried out on a μ-bondapack C18 column using acetonitrile:0.005 M tetrabutylammonium bromide (10:90) mixture, pH 2, as mobile phase. Quantitative determination was performed by ultraviolet detector at 278 nm. The method was specific and validated with a limit of detection of 20 ng/ml and limit of quantitation of 50ng/ml. The intra- and inter-day coefficients of variation were in the range of 1.51-4.48% and 4.02-7.3%, respectively. The recovery of method was 94.27±1.91%. The method was applied to a bioequivalence study of two formulations containing 500 mg ciprofloxacin.

KEYWORDS:

Ciprofloxacin; Human plasma; HPLC; Bioequivalence.

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