HPLC法同时测定小儿化毒散中3种成分的含量  

Simultaneous Determination of 3 Components in Xiaoer Huadu Powder by HPLC

作　　者：曾桢 艾光丽 李婷婷 文永盛 周世玉 

机构地区：[1]成都市食品药品检验研究院,成都610045 [2]成都中医药大学药学院,成都611130

出　　处：《中国药房》2017年第24期3405-3408,共4页China Pharmacy

基　　金：国家药品标准提高暨2015年版药典科研项目;成都市食品药品监督管理局项目(No.201703)

摘　　要：目的:建立同时测定小儿化毒散中芍药苷、盐酸小檗碱、甘草酸铵含量的方法。方法:采用高效液相色谱法。色谱柱为Waters SunFire^(TM)-C_(18),流动相为乙腈-0.1%磷酸溶液(梯度洗脱),流速为1.0 mL/min,检测波长为238 nm,柱温为25℃,进样量为10μL。结果:芍药苷、盐酸小檗碱、甘草酸铵检测质量浓度线性范围分别为8.808～88.08μg/mL(r=0.999 8)、1.778～17.78μg/mL(r=0.999 6)、2.533～25.33μg/mL(r=0.999 9);定量限分别为4.404、0.889、2.533μg/mL,检测限分别为1.101、0.445、1.267μg/mL;精密度、稳定性、重复性试验的RSD<2%;加样回收率分别为95.08%～99.61%(RSD=1.77%,n=9)、96.93%～99.94%(RSD=0.92%,n=9)、98.33%～102.05%(RSD=1.27%,n=9)。结论:该方法简单、准确、重复性好,可用于小儿化毒散中芍药苷、盐酸小檗碱、甘草酸铵含量的同时测定。OBJECTIVE： To establish a method for simultaneous determination of paeoniflorin, berberine hydrochloride and ammonium glycyrrhizinate in Xiaoer huadu powder. METHODS： HPLC method was adopted. The separation was performed on Wa- ters SunFirerU-C18 column with mobile phase consisted of acetonitrile-0.1% phosphoric acid （gradient elution） at the flow rate of 1.0 mL/min. The detection wavelength was set at 238 nm, and column temperature was 25℃. The sample size was 10 μL. RE- SULTS： The linear ranges of paeoniflorin, berberine hydrochloride and ammonium glycyrrhizinate were 8.808-88.08μg/mL （r= 0.999 8）, 1.778-17.78 μg/mL（r=0.999 6）, 2.533-25.33 μg/mL（r=0.999 9）, respectively. LOQ were 4.404, 0.889, 2.533 μg/mL; LOD were 1.101, 0.445, 1.267 μg/mL. RSDs of precision, stability and reproducibility tests were all lower than 2%. The recover- ies were 95.08%-99.61% （RSD= 1.77%, n=9）, 96.93%-99.94% （RSD=0.92%, n=9）, 98.33%-102.05% （RSD= 1.27%, n=9）. CONCLUSIONS： The method is simple, accurate and reproducible, and can be used for simultaneous determination of paeoniflo- fin, berberine hydrochloride and ammonium glycyrrhizinate in Xiaoer huadu powder.

关 键 词：小儿化毒散 高效液相色谱法 芍药苷 盐酸小檗碱 甘草酸铵 

分 类 号：R927.2[医药卫生—药学]