HPLC-ELSD法快速测定生脉注射液中糖类成分含量

目的：利用高效液相色谱-蒸发光散射检测法（HPLC-ELSD）建立生脉注射液中糖类成分快速定量分析方法。方法：采用Alltech Prevail^TM Carbohydrate ES （4.6 mm×250 mm，5 μm）色谱柱，以乙腈和水为流动相梯度洗脱，流速0.8 mL·min^-1，柱温30℃，进样量20 μL，ELSD漂移管温度65℃。结果：生脉注射液中果糖、葡萄糖、蔗糖和麦芽糖成分达到基线分离，浓度在179.0~2 864 μg·mL^-1（r=0.996 8），49~784 μg·mL^-1（r=0.998 1），39~642 μg·mL^-1（r=0.996 8），30~480 μg·mL^-1（r=0.999 3）范围内均呈现良好的线性关系。平均回收率（n=3）在98.34%~100.7%之间，RSD ≤ 3.8%。结论：该方法快速、准确，可用于生脉注射液中糖类成分的定量检测。

Fast quantitative analysis of saccharides in Shengmai injection from different pharmaceutical factories by HPLC-ELSD

OBJECTIVE To establish a HPLC-ELSD method for fast simultaneous determination of four saccharides in Shengmai injection.METHODS These four saccharides were analyzed on an Alltech Prevail^TM Carbohydrate ES (4.6 mm×250 mm,5 μm) column by a gradient elution using aqueous solution and acetonitrile as the mobile phase at 30℃ column temperature.The flow rate was 0.8 mL·min^-1,and the ELSD was at 65℃.RESULTS The results showed good linearity in the range of 179.0-2 864 μg·mL^-1 (r=0.996 8),49-784 μg·mL^-1 (r=0.998 1),39-642 μg·mL^-1 (r=0.996 8),and 30-480 μg·mL^-1 (r=0.999 3).The average recoveries of the four constituents ranged between 98.34% and 100.7% (RSD ≤ 3.8%).CONCLUSION This method is simple,rapid and sensitive,and can be used for quantification the saccharides in Shengmai injection.