甲磺酸多沙唑嗪片人体生物等效性试验研究

Determination of the Cefixime Concentrationin Human Plasma By HPLC-MS/MS

目的：建立HPLC—MS／MS法测定人体血浆中甲磺酸多沙唑嗪浓度的方法。方法：以KromasilC_18（4．6mm×250mm，5μm）为色谱柱，流动相为乙腈：20mM乙酸胺（含0．3％甲酸）水溶液（55：45），流速为0．30mL·min-1，柱温为25℃，进样器温度为4℃，进样量为10μL，内标物为吡格列酮。结果：甲磺酸多沙唑嗪在血浆浓度0．3～100ng／mL范围内线性良好，定量下限为0．3ng／mL，日内RSD≤6．0％，日间RSD≤6．3％，回收率为96．58％～100．16％。结论：该法灵敏，检测结果准确，适用于甲磺酸多沙唑嗪片的人体生物等效性研究。

Objective： To establish a quantified analytical method for determination of Doxazosin Mesylate in human plasma by HPLC-MS/MS. Methods： The HPLC-MS/MS conditions adopted were column Kromasil C_18 （4. 6mm × 250mm, 5μm） ; a mobile phase of acetonitrile ： 20mm ammonium acetate（containing 0.3% methanoic acid, 55 ： 45）;the flow rate was 0.30 mL · min-1 and the column temperature was 25℃, the injector temperature was 4℃ ;the injection volume was 10μL , Pioglitazone was used as inter- nal standard. Results：In human plasma, the standard curve was linear from 0.3 . 100 ng · mL-1 , The lower limit of quantification was 0.3ng · mL-1. The RSD of intra-day was less than 6.0% ,the RSD of inter-day was less than 6.3%, and the method recovery rate was 96.58 % - 100.16 %. Conclusion：The method simple, easy operation, sensitive and accurate, and suitable for Doxazosin Mesylate human bioequivalence research.