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目的:建立测定人血浆中舍吲哚浓度的高效液相色谱法。方法:以DiamonsilTMC18柱(150mm×4.6mm,5μm)为色谱柱;流动相为0.03mol.L-1磷酸二氢钾水溶液(调pH6.4)-乙腈(22∶78);流速:0.8mL.min-1;柱温:40℃;检测波长:258nm。以醋酸乙酯与二氯甲烷(80∶20)为提取剂。结果:舍吲哚的高、中、低(320.0,40.0,5.0μg.L-1)3种浓度平均相对回收率分别为98.62%,99.71%,101.82%;提取回收率分别为86.47%,84.32%,79.56%。日内、日间差RSD均低于7%(n=5);分析方法的检测限为5.0μg.L-1;线性范围为5.0～320.0μg.L-1。曲线方程:Y=97.19X+3.16,r=0.999 1(n=7)。结论:该方法灵敏、准确、简单、快速,可用于临床血药浓度监测和药动学研究。
Objective: To establish a HPLC method for the determination of sertindole in human plasma. METHODS: Diamonsil TMC18 column (150 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase was 0.03 mol L -1 potassium dihydrogen phosphate (adjusted to pH 6.4) -acetonitrile (22:78). The flow rate was 0.8 mL. min-1; column temperature: 40 ℃; detection wavelength: 258nm. Ethyl acetate and dichloromethane (80:20) as extractant. Results: The average relative recoveries of three high, middle and low concentrations of sertindole were 98.62%, 99.71% and 101.82%, respectively. The recovery rates of sertindole were 86.47% and 84.32%, respectively %, 79.56%. The intra-day and inter-day RSDs were all less than 7% (n = 5). The detection limit was 5.0μg.L-1 for the analytical method and 5.0-320.0μg.L-1 for the linear range. Curve equation: Y = 97.19X + 3.16, r = 0.999 1 (n = 7). Conclusion: The method is sensitive, accurate, simple and rapid, which can be used for clinical blood drug concentration monitoring and pharmacokinetic studies.