Abstract
Objective To set up a RP - HPLC method for the determination of gliclazide con-centration in human plasma. Methods Gliclazide was extracted from plasma and with ethyl acetate after acidification and then concentrated. The separation was performed on Kromasil C18 (5μm,4. 6 mm × 250mm) column. The mobile phase consisted of methnol and 0. 3% acetic acid water solution (containing0. 09% triethylamine) with the ratio of 70:30 (v/v) and the flow rate was 1.0 ml/min. The UV detective wavelength was set at 219 nm. Injection volume was 20 μl. Results Gliclazide had strong absorption un-der the optimal chromatographic condition and impurity did not interfere the determination of gliclazide in plasma. Excellent linear relationship was obtained from the range of 78. 125 ～ 10 000 μg/L and the linear regression equation was C = 6. 0112A - 19. 9856, (r = 0. 9 999). The lower limit of quantization was 39. 0625 μg/L for gliclazide under this condition. The RSDs of inter - day and intra - day were less than 15% (n = 5), the relative recoveries were within 90% and the absolute recovery was higher than 75 %.Conclusions The method is simple, rapid, accurate and can be used to determinate the gliclazide con-centration in plasma and for study of pharmacokinetics. Key words: Gliclazide ; HPLC ; Concentration in plasma; Determination
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