Abstract

Simultaneous Determination Of Carbamazepine In Human Plasma By HPLC-DAD: Assay Development, Validation And Application To A Clinical Study

Author(s): Yucel KADIOGLU, Fatma DEMIRKAYA, Yilmaz CAPAN

A simple, sensitive, precise, accurate and specific HPLC method for the determination of CBZ in human plasma was developed and validated. The CBZ was isolated from human plasma by liquid-liquid extraction, gave good results with chloroform. The method was linear in the concentration range 0.5 to 25 μg ml-1 (r>0.998). Recovery for CBZ was greater than 91.7 %. The limit of quantification (LOQ) and the limit of detection (LOD) were 0.15 μg ml-1 and 0.10 μg.ml-1, respectively. Inter-batch precision, expressed as the relative standard deviation (RSD), ranged from 0.79 to 6.30 % for intra day and from 1.60 to 1.95 % for inter day and accuracy was better than 90 %. Analysis of CBZ concentrations in plasma samples from six healthy volunteers following oral administration of single dose of CBZ (Tegretol  CR 200 (200 mg)) provided the following pharmacokinetic data (mean ± SD): Cmax, 1.550±0.468 μg ml-1; AUC0-72 , 52.190±18.942 μg h mL-1; AUC0- 8, 68.306±21.698 μg h ml-1; Tmax, 6,120±6,632 h; t½ 34.270±16.787 h; CL, 3.2602 l min-1.