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目的建立超高效液相串联质谱(UPLC-MS/MS)法测定新型胃动力候选药(S)-MP 3950在大鼠血浆中的浓度并应用于药代动力学研究。方法血浆样品用乙酸乙酯提取,色谱柱为ACQUITY UPLC~BEH C18柱(2.1 mm×50 mm,1.7μm);流动相为甲醇-5 mmol·L~(-1)醋酸铵(含体积分数为0.1%的甲酸)(55∶45),流速为0.2 mL·min~(-1),柱温30℃;质谱检测用电喷雾离子(ESI)源,正离子模式下采用多反应监测(MRM)模式,分析时间为3.0 min。用DAS 2.0软件以非房室模型计算药代动力学参数。结果 (S)-MP 3950在大鼠血浆中的线性范围为10~5000μg·L~(-1)。定量下限为10μg·L~(-1)。日内、日间精密度(RSD)均不大于7.9%,准确度(RE)为0.1%~8.5%。结论此方法快速、灵敏,准确,成功应用于大鼠血浆中(S)-MP 3950浓度的测定及其药代动力学研究。
OBJECTIVE To establish a method for the determination of the concentration of new gastric drug candidate (S) -MP 3950 in rat plasma by UPLC-MS / MS and to study its pharmacokinetics. Methods The plasma samples were extracted with ethyl acetate. The chromatographic column was ACQUITY UPLC ~ BEH C18 column (2.1 mm × 50 mm, 1.7 μm). The mobile phase was methanol-5 mmol·L -1 ammonium acetate (0.1% formic acid) (55:45), the flow rate was 0.2 mL · min -1 and the column temperature was 30 ℃. The electrospray ionization mass spectrometry (ESI) ) Mode, the analysis time is 3.0 min. Pharmacokinetic parameters were calculated using DAS 2.0 software in a non-compartmental model. Results The linear range of (S) -MP 3950 in rat plasma was 10-5000 μg · L -1. The lower limit of quantitation was 10μg · L -1. Day and day precision (RSD) were not more than 7.9%, accuracy (RE) of 0.1% to 8.5%. Conclusion The method is rapid, sensitive and accurate and has been successfully applied to the determination of (S) -MP 3950 in rat plasma and its pharmacokinetics.