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目的:建立测定盐酸莫雷西嗪片的高效液相色谱法。方法:色谱柱为Agilent Zorbax XDB-C18柱(150mm×4.6mm,5μm);流动相为乙腈-水(含0.01%七氟丁酸)(60∶40);流速1.0mL.min-1;以氯氮平作为内标,检测波长为268nm。结果:莫雷西嗪与内标的保留时间分别为5.5min和11.5min。在莫雷西嗪为1~100mg.L-1范围内线性关系良好(r=0.999 9),平均回收率为99.9%,RSD为1.63%(n=6)。结论:该方法简便快速,灵敏、准确,适用于测定盐酸莫雷西嗪片中莫雷西嗪的含量,可作为莫雷西嗪制剂的质量控制方法。
Objective: To establish a HPLC method for the determination of methicillin hydrochloride tablets. Methods: The column was Agilent Zorbax XDB-C18 column (150mm × 4.6mm, 5μm); the mobile phase consisted of acetonitrile-water with 0.01% heptafluorobutyric acid (60:40); the flow rate was 1.0mL.min-1; Clozapine as an internal standard, detection wavelength of 268nm. Results: The retention times of methicillin and internal standard were 5.5 and 11.5 min respectively. In the range of 1 ~ 100 mg.L-1, the average response rate was 99.9% and the RSD was 1.63% (n = 6). Conclusion: The method is simple, rapid, sensitive and accurate and is suitable for the determination of the content of moresilazine in the tablets of methicillin hydrochloride. It can be used as the quality control method for the preparation of.