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目的:建立适合抗疟新药三氟乙酰伯氨喹及其合成前体伯氨喹的高效毛细管电泳定量检测方法。方法:在Bio-RadHPE-100型毛细管电泳仪上,以自由区带电泳分离模式探讨电泳体系各因素对伯氨喹及三氟乙酰伯氨喹分离的影响;并选择甲基麻黄素为内标,柱上210nm检测,进行定性定量分析。结果:伯氨喹、三氟乙酰伯氨喹在测定浓度范围内,峰面积比与被测物浓度的线性关系良好。重现性考察结果表明,6次测量迁移时间的相对标准差小于06%,峰面积比的日内日间相对标准差小于50%。结论:高效毛细管电泳在抗疟新药三氟乙酰伯氨喹及其合成前体伯氨喹定性定量方面的成功应用,为药物合成过程产品质量控制提供更为简便、快速的检测手段。
OBJECTIVE: To establish a method for the quantitative determination of primaquine, a new anti-malarial drug, primaquine and its synthetic precursor, primaquine. Methods: On the Bio-RadHPE-100 capillary electrophoresis system, the separation of primaquine and primaquine Trifluoroacetate by different electrophoresis systems was studied by free zone electrophoresis separation mode. Methyl ephedrine was selected as the internal standard , Column 210nm detection, qualitative and quantitative analysis. Results: The calibration curves of primaquine and primaquine difluoride showed good linear relationship with the concentration of analyte in the range of concentration. The reproducibility results showed that the relative standard deviations of 6 measurements were less than 06%, and the relative standard deviations of days and days were less than 50%. Conclusion: The high performance capillary electrophoresis has been successfully applied in the qualitative and quantitative analysis of primary antimalarial drug primaquine and its synthetic precursor primaquine, providing a more simple and rapid detection method for product quality control during drug synthesis.