Determination and clinical pharmacy application of quetiapine fumarate in human serum by RP-HPLC
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摘要: 目的 建立测定血清中富马酸喹硫平浓度的反相高效液相色谱(RP-HPLC)法并将其应用于临床。 方法 含药血清碱化后用乙醚萃取,应用RP-HPLC技术检测,色谱柱为Zorbax Eclipse XDB-C18,流动相为甲醇-水(70:30,含0.5%三乙胺,0.4%冰乙酸),流速为0.6 ml/min,检测波长为254 nm,柱温为35 ℃。对建立的方法应用于临床给药分析。 结果 血清中富马酸喹硫平与血清中杂质可完全分离,在50~1 000 ng/ml浓度范围内呈良好的线性关系(r=0.999 5),方法学回收率为98.2%~100.1%,萃取回收率为75.2%~84.6%,日间精密度RSD在0.8%~3.7%之间,日内精密度RSD在1.4%~5.1%之间,最低检测限(S/N=3)为2.1 ng/ml。将此方法应用于临床药学取得了较好的效果。 结论 该方法操作简便,结果准确,重现性好,灵敏度高,适用于富马酸喹硫平血药浓度监测,对指导临床合理用药,发现药物不合理联用等具有重要的意义。Abstract: Objective To establish a method for the determination of quetiapine fumarate in human serum by RP-HPLC and apply it into clinical. Methods Extracting with ethyl ether after serum-drug was alkalized, and then determined by RP-HPLC. The determination was performed on Zorbax Eclipse XDB-C18 column with mobile phase consisted of methanol-water (70:30, containing 0.5% triethylamine and 0.4% glacial acetic acid) at the flow rate of 0.6 ml/min. The detection wavelength was set at 254 nm, and the column temperature was 35 ℃. The method would be applied into analysis of clinical medication. Results Quetiapine fumarate and the impurities could be completely separated, and the linear range of quetiapine fumarate were 50-1 000 ng/ml(r=0.999 5).The recovery of the method was 98.2%-100.1% and the recovery of extracting was 75.2%-84.6%. RSD of intra-day was within 0.8%-3.7% and RSD of inter-day was within 1.4%-5.1%.The limit of quantitation for quetiapine fumarate was 2.1 ng/ml.This method had been applied into clinical pharmacy and achieved a good effects. Conclusions The method is simple, accurate, reproducible, and sensitive for determination of quetiapine fumarate in human serum. It has important significance on instructing the rational use of clinical medicine and discovering the unreasonable drug combination.
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Key words:
- RP-HPLC /
- quetiapine fumarate /
- serum concentration /
- clinical pharmacy
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