HPLC-ELSD测定乌贝益胃胶囊中贝母素甲和贝母素乙含量

Determination of Peimine and Peiminine in Wubei Yiwei Capsules by HPLC-ELSD

目的建立高效液相色谱-蒸发光散射检测器法(HPLC-ELSD)同时测定乌贝益胃胶囊中贝母素甲和贝母素乙含量的方法,并对10批样品进行考察,制定含量限度。方法采用HPLC-ELSD,色谱柱为Eclipse XDB C18(150 mm×4.6 mm,5μm),流动相为乙腈-水-二乙胺(65∶35∶0.05),柱温为30℃,流速为1.0 mL/min。ELSD参数:漂移管温度为80℃,载气流速为2.5 L/min。结果贝母素甲和贝母素乙进样量分别在0.294～2.944μg、0.424～4.240μg范围内与各自峰面积的对数值呈线性关系,平均加样回收率分别为98.13%(RSD=1.02%,n=6)、98.38%(RSD=0.92%,n=6)。结论本方法准确可靠,重复性好,为乌贝益胃胶囊质量标准的制定提供了依据。

Objective To develop an HPLC-ELSD method for the determination of peimine and peiminine in Wubei Yiwei capsules. Methods HPLC-ELSD method was performed on Eclipse XDB C18 column （150 mm× 4.6 mm, 5 μm） with acetonitrile-water-diethylamine （65 ： 35 ： 0.05） as the mobile phase and flow rate of 1.0 mL/min. The temperature of column was at 30℃, the detector drift tube temperature was set at 80 ℃ and the nitrogen flow rate was 2.5 L/min. Results The calibration curves for peimine and peiminine were linear in the range of 0.294--2.944 μg and 0.424--4.240 μg, respectively. The average recoveries （n =6） were 98.13% IRSD：l.02%） and 98.38% （RSD=0.92%）, respectively. Conclusion The method is accurate and repeatable, and provide basis for the quality standard of Wubei Yiwei capsules.