HPLC法同时测定复方甘草酸苷注射液中甘氨酸与盐酸半胱氨酸的含量

Simultaneous determination of glycine and cyeteine hydrochloride in compound glycyrrhizin injection by HPLC

目的:建立HPLC法同时测定复方甘草酸苷注射液中甘氨酸与盐酸半胱氨酸的含量。方法:采用Dikma ODS-C18色谱柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.05 mol.L-1磷酸二氢钾+0.05 mol.L-1庚烷磺酸钠溶液(磷酸调节pH值至3.0,2∶98);流速为1.0 mL.min-1;检测波长为205 nm。结果:甘氨酸在120～280μg.mL-1的浓度范围内与峰面积呈良好的线性关系(r=0.999 5);平均回收率为99.87%,RSD为0.37%;盐酸半胱氨酸在6～14μg.mL-1的浓度范围内与峰面积呈良好的线性关系(r=0.999 9);平均回收率为101.30%,RSD为0.71%(n=9)。结论:本法简单、准确、重复性好,可用于复方甘草酸苷注射液的质量控制。

Objective：To establish a HPLC method for simultaneous determination of glycine and cysteine hydrochloride in compound glycyrrhizin injection. Methods：A Dikma ODS-Ci8 column（250mm×4.6mm,5μm） was used. The mobile phase consisted of methanol-0.05 mol·L-1 potassium dihydrogen phosphate and 0.05mol·L^-1 1-heptanesulfonic acid sodium solution （pH adjusted to 3. 0 with phosphate, 2：98）. The flow rate was 1. 0 mL.min-1, and the detection wavelength were 205 nm. Results：Good linearities between 120 -280μg·mL-1 for glyeine and 6 -14 μg·mL-1 for cysteine hydrochloride were showed respectively. The mean recoveries of glycine and cysteine hydrochloride were 99.87% , RSD = 0.37% （ n = 9 ） and 101.30% , RSD = 0.71% （ n = 9 ） , respectively. Conclusion：The method is accurate, convenient and repeatable for simultaneous determining glycine and cysteine hydrochloride in compound glycyrrhizin injection.