HPLC-ELSD测定注射用丹参多酚酸中甘露醇含量

目的：采用合适的分离方法将注射用丹参多酚酸中甘露醇与酚酸类物质分离后,用HPLC-ELSD测定注射用丹参多酚酸中甘露醇的含量。方法：采用Prevail Carbohydrate ES柱（4.6 mm×250 mm,5μm）;流动相：以乙腈-四氢呋喃（100∶2）为流动相A,0.1%乙酸水为流动相B,A∶B=83∶17进行等度洗脱;流速：0.8 mL.min-1;以ELSD检测器进行检测,参数设置为：增益10,气压25 psi,漂移管65℃,Neb heater 60%;柱温：30℃。结果：甘露醇峰面积的自然对数值与浓度（μg.mL-1）的自然对数值呈良好的线性关系,甘露醇的线性回归方程为y=1.3986x＋2.3695,R2=0.9991,线性范围为59.84~598.40μg.mL-1,平均回收率为102.86%（RSD 2.48%）。结论：本方法操作简单,且重现性好,可用于注射用丹参多酚酸中甘露醇的含量测定。

Determination of Mannitol in Salvianolic Acid Extract for Injection by HPLC-ELSD

Objective： After separating the Mannitol from the salvianolic acid extract for injection, HPLC-ELSD was used to detect the Mannitol in the salvianolic acid extract for injection. Methods： Chromatographic column was Prevail Carbohydrate ES （ 250 mm × 4.6 mm, 5μm ） at the gradient elution mode with the flow rate of 0.8 mL · min-1 , mobile phase was aeetonitrile-tetrahydrofuran （ 100 ： 2 ） and 0.1% Acetic Acid-water, the ratio was 83 to 17, column temperature was kept at 30 ℃, an evaporate light scattering detector（ ELSD ）was used as detector with gas press of 25 psi and drift tube temperature of 65 ~C, gain was 10 and the Neb heater was 60%. Result： Mannitol showed a good linearity, the regress equation for Mannitol was y=1.3986x＋2.3695, R2=0.9991, and the linear range was 59.84-598.40 μ g ·mL-l. The average recoveries of Mannitol was 102.86%, RSD 2.48%. Conclusion ： The method is simple and accurate for determination of Mannitol in the salvianolic acid extract for injection.