固相萃取高效液相色谱法测定氯氮平血药浓度

Determination of clozapine in serum by solid phase extraction and high performance liquid chromatography

目的建立高效液相色谱测定人血清中氯氮平(抗精神病药)浓度的方法。方法血清样品上SPE柱,甲醇为洗脱剂,65℃氮气吹干后复溶进样测定。用Hypersil C18色谱柱,流动相为甲醇-水=75∶25(加入0.3%三乙胺,用冰醋酸调节pH=8.0),流速为0.8 mL.min-1,检测波长243 nm。结果氯氮平血清样品线性范围为0.05～10.00 mg.L-1,低、中、高3种不同浓度(0.22,1.08,3.22 mg.L-1)方法回收率分别为102.0%,99.7%,99.4%,日内、日间RSD均小于5%。结论本方法准确性好,灵敏度高,操作简便,可以满足氯氮平血药浓度监测和药物中毒分析的要求。

Objective To establish a HPLC method for determination of the concentration of clozapine in serum.Methods The analysis was conducted with Hypersil C18 column.Methanol-water（75∶25）（0.3% triethylamine was added and glacial acetic acid was used to regulate pH to 8.0） was served as mobile phase,the flow number was 0.8 mL·min-1,and the detecting wavelengh was at 243 nm.Serum sample was applied to SPE column,and the eluting agent was methanol.The eluant was collected and was dried in 65 ℃ with Nitrogen gas.Results The linear range of clozapine in serum was 0.05-10.00 mg·L-1.The recovery rate of low concentration,moderate concentration and high concentration（0.22,1.08,3.22 mg·L-1） was 102.0%,99.7%,99.4% respectively.Both of the intra-day and inter-day RSD were less than 5%.Conclusion This method is accurate,sensitive,and simple.It is suitable for the determination of the concentration of clozapine in serum and the analysis of drug poisoning of clozapine.