HPLC-ELSD梯度洗脱法测定八珍益母丸(浓缩丸)中水苏碱的含量  

Determination of stachydrine in Bazhen Yimu Pills(concentrated pills)by HPLC-ELSD under gradient elution

作　　者：胡彬 越亮 孙建彬[1] 喻贵英 王欣[1] 彭爽 罗维早[1] HU Bin;YUE Liang;SUN Jianbin;YU Guiying;WANG Xing;PENG Shuang;LUO Weizao(Chongqing Academy of Chinese Materia Medica,Chongqing 400065,China;Chongqing Taiji Group Tongjunge Pharmaceutical Co.Ltd.,Chongqing 401336,China)

机构地区：[1]重庆市中药研究院,重庆400065 [2]太极集团重庆桐君阁制药厂有限公司,重庆401336

出　　处：《中国药品标准》2022年第1期91-94,共4页Drug Standards of China

摘　　要：目的:建立八珍益母丸(浓缩丸)中水苏碱的HPLC-ELSD含量测定方法。方法:色谱柱为ME-Mother-wort(4.6 mm×250 mm,5μm),流动相:乙腈(A)-0.2%冰醋酸溶液,梯度洗脱,柱温:35℃,流速:1 mL·min^(-1),ELSD检测器:雾化温度:60℃;蒸发温度:80℃;N_(2)流速:1.2 L·min^(-1)。结果:水苏碱的线性范围为0.0958~6.1320μg,r为0.9997,加样回收率为105.01%,RSD小于2%。结论:该方法简便、准确、可靠、可用于八珍益母丸(浓缩丸)的质量控制。Objective:To establish an HPLC-ELSD method for determination of stachydrine in Bazhen Yimu pills(concentrated pills).Methods:The test was performed in ME-Motherwort column(4.6 mm×250 mm,5μm)under the gradient elution of acetonitrile and 0.2%acetic acid solution.The flow rate was 1 mL·min^(-1)and the column temperature was 35℃.The evaporative light-scattering detector(ELSD)detector was used,the atomization temperature was 60℃and the evaporation temperature was 80℃.The N_(2)flow rate was set at 1.2 L·min^(-1).Results:The linear range of stachydrine fell into 0.0958-6.1320μg(r=0.9997).The average recovery was105.01%with RSD less than 2%.Conclusion:The established method is simple,accurate and reliable.It can be used for the quality control of Bazhen Yimu pills(concentrated pills).

关 键 词：八珍益母丸(浓缩丸) HPLC-ELSD 水苏碱 含量测定 质量控制 

分 类 号：R921.2[医药卫生—药学]