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    正相高效液相色谱法测定注射用右旋兰索拉唑中左旋异构体的含量

    Determination of Levoisomer in (R)-Lansoprazole for Injection by Normal Phase High Performance Liquid Chromatography

    • 摘要: 将注射用右旋兰索拉唑粉末用甲醇溶解配制成5.00 mg·L-1的样品溶液,在以下条件下进行色谱分析:采用Chiralpak ID手性色谱柱(4.6 mm×250 mm,5 μm)为固定相,柱温为35℃,流动相为正己烷-异丙醇-冰乙酸(70+30+0.2)混合液,流量为0.6 mL·min-1,二极管阵列检测器,检测波长为285 nm。结果表明:左旋兰拉唑的质量浓度在0.48~4.81 mg·L-1内与其峰面积呈线性关系,检出限(3S/N)为2.4×10-3mg·L-1,测定下限(10S/N)为4.8×10-3mg·L-1。加标回收率在97.5%~103%之间,测定值的相对标准偏差(n=6)小于1.6%。

       

      Abstract: The (R)-lansoprazole powder for injection was dissolved in methanol to prepare a 5.00 mg·L-1 sample solution, and chromatographic analysis was carried out under the following conditions:Chiralpak ID chiral column (4.6 mm×250 mm, 5 μm) was used as stationary phase, the column temperature was 35℃, the mobile phase was a mixture of n-hexane, isopropanol and glacial acetic acid (70+30+0.2), the flow rate was 0.6 mL·min-1, and the diode array detector was used for detection at the wavelength of 285 nm. The results showed that, linear relationship was found between peak area and mass concentration of (S)-lansoprazole in the range of 0.48-4.81 mg·L-1, the detection limit (3S/N) was 2.4×10-3mg·L-1, and the lower limit of determination (10S/N) was 4.8×10-3mg·L-1. Values of recovery obtained by standard addition method were in the range of 97.5%-103%, and RSDs (n=6) were less than 1.6%.

       

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