胶束毛细管电泳法同时测定小青龙颗粒中的盐酸麻黄碱、盐酸伪麻黄碱、盐酸甲基麻黄碱与芍药苷含量

目的:建立同时测定小青龙颗粒中盐酸麻黄碱、盐酸伪麻黄碱、盐酸甲基麻黄碱、芍药苷含量的方法。方法:采用胶束毛细管电泳法。分离通道为熔融石英毛细管柱,缓冲溶液为10 mmol/L硼砂-10 mmol/L十二烷基硫酸钠的混合溶液(95∶5,pH为10.5),检测波长为195 nm,分离电压为20 kV,毛细管柱温为15℃,压力进样0.5 psi×5 s。取2个厂家各2批小青龙颗粒测定其中盐酸麻黄碱、盐酸伪麻黄碱、盐酸甲基麻黄碱、芍药苷的含量,并将测定结果与采用2015年版《中国药典》规定的高效液相色谱法的测定结果进行比较。结果:盐酸麻黄碱、盐酸伪麻黄碱、盐酸甲基麻黄碱、芍药苷检测质量浓度线性范围分别为10～160、10～160、1～100、10～500μg/mL(r为0.997 9～0.999 8);精密度、重复性和稳定性试验中的RSD均≤2.74%(n=5～6),平均回收率分别为101.55%、101.62%、100.15%、101.85%,RSD均≤3.94%(n=6);4种成分采用胶束毛细管电泳法与高效液相色谱法测定结果基本一致。结论:建立的胶束毛细管电泳法简捷、快速、灵敏,可同时测定小青龙颗粒中上述4种成分的含量。

Simultaneous Determination of Ephedrine Hydrochloride,Pseudoephedrine Hydrochloride,Methamphetamine Hydrochloride and Paeoniflorin in Xiaoqinglong Granule by Micellar Capillary Electrophoresis Method

OBJECTIVE:To establish the method for simultaneous determination of ephedrine hydrochloride,pseudoephedrine hydrochloride,methamphetamine hydrochloride and paeoniflorin in Xiaoqinglong granule.METHODS:Micellar capillary electrophoresis(MCE)method was adopted.The optimum conditions for the separation were as follows as a fused silica capillary column as the separation channel,the buffer solution composed of 10 mmol/L borax-10 mmol/L SDS(95∶5,pH 10.5),detection wavelength of 195 nm,separation voltage of 20 kV,capillary column temperature of 15℃,the sampling at a pressure for 0.5 psi×5 s.Two batches of Xiaoqinglong granules were collected from 2 manufacturers to determine the contents of ephedrine hydrochloride,pseudoephedrine hydrochloride,methamphetamine hydrochloride and paeoniflorin.The results of content determination were compared with the results determined by HPLC method stated in Chinese Pharmacopeia of 2015 edition.RESULTS:The linear range of ephedrine hydrochloride,pseudoephedrine hydrochloride,methamphetamine hydrochloride and paeoniflorin were 10-160,10-160,1-100,10-500μg/mL(r=0.997 9-0.999 8),respectively.RSDs of precision,reproducibility and stability tests were all≤2.74%(n=5-6).The average recoveries were 101.55%,101.62%,100.15%,101.85%(RSD≤3.94%,n=6),respectively.The contents of 4 components determined by micellar capillary electrophoresis were in accordance with the results of HPLC method.CONCLUSIONS:The established MCE method is simple,quick and sensitive,and can be used for simultaneous determination of 4 components mentioned above in Xiaoqinglong granule.