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目的:建立测定甲磺酸沙芬酰胺中对映异构体含量的方法。方法:采用HPLC法,色谱柱:Chiralpak AS-H柱(250mm×4.6 mm,5μm);流动相:正己烷-乙醇-二乙胺(75∶25∶0.1);流速:1.0 ml·min~(-1);检测波长:225 nm;柱温:35℃。结果:甲磺酸沙芬酰胺与其对映异构体之间的分离度大于2.0;两者分别在1.007~2517.500μg·ml~(-1)和0.909~2273.200μg·ml~(-1)范围内呈良好的线性关系,r均为0.999 0;对映异构体的平均加样回收率为104.9%,RSD为2.3%(n=9)。结论:该方法准确、快速,可用于甲磺酸沙芬酰胺产品中对映异构体的含量测定。
Objective: To establish a method for the determination of enantiomers in methanesulfonamide methanesulfonamide. Methods: The HPLC method was adopted. Chiralpak AS-H column (250 mm × 4.6 mm, 5 μm) was used as the mobile phase. The mobile phase consisted of hexane: ethanol: diethylamine (75:25:0.1) -1); detection wavelength: 225 nm; column temperature: 35 ℃. Results: The separation between methanesulfonic acid and its enantiomers was more than 2.0. The differences were between 1.007 ~ 2517.500μg · ml ~ (-1) and 0.909 ~ 2273.200μg · ml ~ (-1) respectively (R = 0.999 0). The average recoveries of enantiomers were 104.9% with RSD of 2.3% (n = 9). Conclusion: The method is accurate and rapid and can be used for the determination of enantiomers in methanesulfonic acid methanesulfonamide product.