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目的:建立测定人血浆中氯诺昔康浓度的方法。方法:采用高效液相色谱法,以美洛昔康为内标,血浆样品以直接蛋白沉淀法处理,色谱柱为Agilent C_(18)(250mm×4.6mm,5μm),以甲醇-水(含0.05%三乙胺,用HCl调节pH至6.0)(55:45)为流动相,流速为1.0 ml·min~(-1),柱温为室温,检测波长为378nm,进样量为20μl。结果:氯诺昔康血药浓度在2～500 ng·ml~(-1)浓度范围内线性关系良好(r=0.995 0);高、中、低3种浓度的方法回收率为96.29%～104.00%,提取回收率>92.0%,日内、日间RSD分别为2.57%～6.41%和1.73%～6.62%。结论:本方法灵敏度、准确度及回收率均能达到人体血药浓度测定的要求,也可用于临床人体药动学的研究。
Objective: To establish a method for the determination of lornoxicam in human plasma. Methods: Meloxicam was used as internal standard and plasma samples were separated by direct protein precipitation. The column was Agilent C 18 (250 mm × 4.6 mm, 5 μm) 0.05% triethylamine, adjusted to pH 6.0 with HCl (55:45) as the mobile phase at a flow rate of 1.0 ml · min -1 .The column temperature was at room temperature, the detection wavelength was 378 nm and the injection volume was 20 μl. Results: The linear range of lornoxicam concentration was in the range of 2 ~ 500 ng · ml -1 (r = 0.995 0). The recoveries of high, medium and low concentrations were 96.29% 104.00%. The recovery rate was> 92.0%. The intra-day and interday RSD were 2.57% -6.41% and 1.73% -6.62%, respectively. Conclusion: The sensitivity, accuracy and recovery of this method can meet the requirements of human plasma concentration determination, and can also be used in clinical human pharmacokinetic studies.