Muhammad Talha Usmani, Muhammad Harris Shoaib, Fahad Siddiqui, Farrukh Rafiq Ahmed, Sabahat Jabeen, Rehana Saeed, Kamran Ahmed, Sadaf Farooqi, Tazeen Hussain, Syed Muhammad Imran.
Modification and validation of liquid chromatographic method for the quantification of ciprofloxacin in human plasma and its application to a bioavailability study..
Pak J Pharm Sci Jan ;34(2):767-72.

A new simple, accurate, precise and sensitive liquid chromatographic method for the analysis of Ciprofloxacin in human plasma, suitable for quantification of drug was developed and validated using HPLC-UV method. The analyte was chromatographically separated from endogenous plasma components on a C-18 reversed phase column (5µm, 25cm × 0.46cm) and detected at 278nm. The sample pretreatment was carried out with acetonitrile on 200µl of plasma. The Lower limit of quantification (LLOQ) was 0.04 µg/ml with linearity in the range 0.04-4 µg/ml and coefficient of correlation value (R)>0.995. The method was successfully validated as per current FDA guidance for necessary parameters and applied to a pilot bioavailability study conducted on six healthy volunteers with marketed Ciprofloxacin 250mg immediate release tablets. The plasma concentrations were subjected to non-compartmental analysis for calculation of pharmacokinetic parameters like C, T, AUC, AUC and t etc. The mean values of C and T were found to be 1.35±0.09µg/ml and 1.25±0.27h respectively while for other pharmacokinetic parameters including AUC, AUC were found to be 5.98±0.96 μg/ml×h and 6.34±1.07μg/ml×h. The drug exhibited half-life (t) of 3.94±0.33h. The obtained results proved the suitability of the method for routine pharmacokinetic studies of Ciprofloxacin.

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