HPLC检测人血浆中厄贝沙坦的浓度

Determination of Irbesartan in Human Plasma by HPLC

关键词:  高效液相色谱法  厄贝沙坦  血药浓度  药动学

Key words:  HPLC  irbesartan  plasma concentration  pharmacokinetics

摘要:

目的 建立人血浆厄贝沙坦检测的高效液相色谱法。方法 血浆经乙醚萃取，以ZORBAX Extend-C₁₈为色谱柱；流动相为乙腈-水-0.1％TFA-0.5 mmol·L^-1 SDS体系，流速为0.8 mL·min^-1；检测波长为242 nm(0~6.5 min)和266 nm(6.5~7.8 min)。结果 厄贝沙坦浓度在0.05~6.00 mg·L^-1内线性关系良好(r=0.999 9)；定量限为0.05 mg·L^-1；高中低3个浓度的相对回收率分别为(103.93±1.09)%、(99.85±0.65)%和(100.95±1.21)%；日内RSD分别为3.04％，1.15％，1.19%，日间RSD分别为4.50%，3.32%，1.18%。结论 本方法准确可靠、简便快速，适用于人血浆厄贝沙坦浓度的测定及其药动学研究。

Abstract:

OBJECTIVE To develop a high performance liquid chromatography method for the determination of irbesartan in human plasma. METHODS The plasma were extracted by diethyl ether. The analytical column was packed with ZORBAX Extend-C₁₈. The mobile phase were acetonitrile-water-0.1% trifluoroacetic acid-0.5 mmol·L^-1 SDS and the flow rate was 0.8 mL·min^-1. The UV detection wavelength was 242 nm(0-6.5min) and 266 nm(6.5-7.8min). RESULTS Excellent liner relationship was obtained in the range of 0.05-6.00 mg·L^-1(r=0.999 9). The limit determination of irbesartan was 0.05 mg·L^-1. The relative recoveries were (103.93±1.09)%, (99.85±0.65)% and(100.95±1.21)% respectively at three concentrations, the intra-day RSD were 3.04%, 1.15% and 1.19% and inter-day RSD were 4.50%, 3.32% and 1.18%, respectively. CONCLUSION The method was accurate, simple, rapid and could be used to determine the irbesartan concentration in human plasma and for study of its pharmacokinetics.