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(150mm×4.6mm,5 μm),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 ～2.944 μg、0.424～4.240 μg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, 5μm) 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% (RSD=1.02%) 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.
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