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

将注射用右旋兰索拉唑粉末用甲醇溶解配制成5.00mg·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,5μm)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0.6mL·min^-1,二极管阵列检测器,检测波长为285nm。结果表明:左旋兰拉唑的质量浓度在0.48~4.81mg·L^-1内与其峰面积呈线性关系,检出限(3S/N)为2.4×10^-3 mg·L^-1,测定下限(10S/N)为4.8×10^-3 mg·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%。

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

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,5μm)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(3 S/N)was 2.4×10^-3 mg·L^-1,and the lower limit of determination(10 S/N)was 4.8×10^-3 mg·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%.