高效液相色谱法测定人血浆中齐拉西酮浓度

HPLC determination of ziprasidone in human plasma

目的:建立高效液相色谱法用于测定人血浆中齐拉西酮浓度。方法:色谱柱为 Hypersil C_(18)(5μm,200mm×5.0mm),甲醇-磷酸盐缓冲液(0.05mol·L^(-1)KH_2PO_4,用 H_3PO_4调 pH 至6.0±0.1)(70:30)为流动相,柱温:35℃,流速1.4mL·min^(-1),检测波长:229nm。结果:齐拉西酮血药浓度在0.0169～1.62μm·mL^(-1)范围内,与峰面积比有良好的线性关系(r=0.9994),最低定量浓度0.0169μm·mL^(-1);平均方法回收率为(103.66±4.19)%(n=15);日内误差≤6.8%,日间误差≤7.4%。结论:本法简单、快速、准确,分离效果良好,灵敏度高,回收率高,日内、日间误差小,可用于临床药代动力学研究。

Objective： To establish an HPLC method for determination of ziprasidone （Zip） in human plasma. Methods：The compounds were separated on a Hypersil C18 column （200 mm ×5.0 mm,5 μm）. The mobile phase was a mixture of methanol - 0. 05 mol · mL^- 1 KH2PO4 in a ratio of 70：30 （ adjusted pH to 6. 0 ± 0. 1 by H3 PO4 ）, the flow rate was 1.4 mL ·min^-1. The column temperature was 35℃. The detection wavelength was UV 229 urn. Results： A good linearity was obtained from 0. 0169 - 1.62 μg · mL^-1 in plasma（r =0. 9994）. The lowest concentration detected was 0. 0169 μg·mL^-1 The average recovery of method was （ 103.66±4. 19）% （n = 15）. The within - day and between -clay RSD were ≤6. 8% and ≤7.4% ,respectively. Conclusion：The mrthod is simple, quick, sensifive, a good recovery, and accurate and can be used for clinical pharmacokinetic study of ziprasidone.