高效液相荧光色谱法测定人血浆中坎地沙坦的浓度

目的建立测定人血浆中坎地沙坦的高效液相荧光色谱（HPLC—FLU）法。方法用正乙醚提取血浆样品，以甲醇-0．02mmol／L磷酸盐缓冲液（pH=3．0，68：32，V／V）为流动相，流速为lmL／min，色谱柱为BaiAn—C18柱（150mm×4．6mm，5μm），柱温为30℃，荧光检测激发波长（λex）265nm，发射波长（λem）395nm。结果血浆内源性杂质不干扰待测物的测定，坎地沙坦质量浓度与峰面积的线性范围为2～300μg／L，定量下限为2μg／L，日内、日间精密度RSD均小于8％。样品3次冻融及提取后，4℃下12h内稳定性良好。结论HPLC—FLU法灵敏、快速、准确、简便、线性范围宽，可用于坎地沙坦的临床药代动力学研究：

Determination of Candesartan in Human Plasma by HPLC with Fluorescence

Objective To establish a HPLC with fluorescence （FLU） method for the determination of candesartan in human plasma. Methods Plasma samples were treated by ethylether. Separation was carried out on the column of BaiAn-C18 （150mm×4.6 mm,5μm） at 30℃,The mobile phase consisted of methanol-0. 02 mmol/L potassium dihydrogen phosphate buffer （pH 3.0;68：32, V/V） pumped at a flow rate of 1 mL/min. The fluorescence detector was operated at an excitation and emission wavelengths 265 and 395 nm, respectively. Results The intrinsic impurity of plasma did not interfere with the determination. The linear range of candesartan oxifen was 2-300 μg/L. The lower limit of quantification was 2 μg/L. The precision of intra- day and inter- day were less than 8%. The stability of unprocessed and processed samples stored at 4 ℃ for 12 h was good. After 3 cycles of freeze and extracting processes,the plasma samples were stable, Conclusion The HPLC- FLU method is fast, sensitive, and accurate. It can be applied to the clinical pharmaeokinetic investigations of candesartan.