Method development and validation of anti-histaminic drug in plasma

A selective, rapid and sensitive reverse phase ultra- performance liquid chromatography method was developed for the quantitative determination of fexofenadine in human plasma. With carbamazepine as internal standard, sample pretreatment involved a one-step extraction with ethyl acetate from 980µl plasma. The sample was analyzed using 10mM KH2PO4 buffer pH 2.5 and acetonitrile (70:30 v/v) as mobile phase. Chromatographic separation was achieved on an ACQUITY UPLC BEH (C-18) column using isocratic elution. The peak was detected using UV-PDA detector set at 210 nm and the total time for chromatographic separation was 10 min. Linear calibration curves were obtained in the concentration range of 30.09-1805.39 ng/ml with a lower limit of quantification of 30.09 ng/ml. The inter and intra- day precision (RSD) values were below 15% and accuracy (RE) was from 1.55 to 5.51 % at all QC levels. Developed method was found to be accurate, precise, selective and rapid for estimation of fexofenadine in plasma and can be used for pharmacokinetic and bioequivalence studies.

Autorentext

Mr.Maulikkumar R. Amin M.Pharm Assistant Professor, Department of Pharmaceutical Chemistry, Kalol Institute of Pharmacy, Kalol-382721 Gujarat, India.