Simultaneous determination of irbesartan and hydrochiorothiazide in human plasma by high performance liquid chromatography and its pharmacokinetic application

ABSTRACT

Development of a simple, rapid and routine assay for the combination lrbesartan Hydrochlorothiazide [IB/HCTZ] for the investigation of their pharmacokinetic parameters in human plasma and bioequivalence study of LB I UCT [300/12.5mg] tablets manufactured locally [Test] and originally [Reference]. After extraction of [IB.HCTZ] from plasma, it was chromatographed with mobile phase consisting of phosphate buffer acetonitrile methanol [652510] at flow rate of 1 ml/min and detected at wavelength of 272 nm. The pharmacokinetic study was conducted in a 2 X 2 crossover design involving 24 volunteers. The criteria used to assess bioequivalence of the two products were AUC[0-t], AUC[0-infinity], C[max], and t[max]. The described method for analysis showed that the recoveries of LB I HCTZ from plasma were 99.63%and 100.793% the limit of detection were 0.015 micro g/ml and 1.5 ng/ml respectively and the regression analysis for the drug concentrations indicated excellent linearity[r>0.999] for both. Statistical analysis [ANOVA] of the measured parameters showed that there was no significant difference between the two products. The HPLC method presented is direct, simple. reproducible, sensitive and linear for the determination of lB/HCT in human plasma and is adequate for its clinical pharmacokinetic studies. besides, the Test was found to be biocquivalent to the Reference and both products can be considered interchangeable in medical practice