HPLC法测定复方甘草酸苷注射液中甘氨酸和盐酸半胱氨酸的含量

目的：建立离子交换高效液相色谱法测定复方甘草酸苷注射液中甘氨酸和盐酸半胱氨酸含量的方法。方法：色谱柱：SHIM—PACKAMINO-NA（10cm×6．0mm），流动相：0．25mol·L^-1磷酸二氢钠溶液（用磷酸调pH3．0），流速：0．35ml·min^-1，柱温：60℃，检测波长：205nm。结果：甘氨酸浓度在0．20～3．20mg·ml^-1范围内与峰面积呈良好线性关系（r=0．9997）；平均回收率为99．1％，RSD=0．6％（n=9）。盐酸半胱氨酸浓度在0．01～0．16mg·ml^-1范围内与峰面积呈良好线性关系（r=0．9991）；平均回收率为101．9％，RSD=0．9％（n=9）。结论：本方法简单、准确、重复性好，可用于该制剂的质量控制。

Determination of Glycine and Cysteine Hydrochloride in Compound Glycyrrhizin Injection by HPLC

Objective ： To establish a method for determination of glycine and cysteine hydroehloride in compound glyeyrrhizin injection by HPLC. Method： The SHIM-PACK AMINO-NA（ 10cm× 6.0 mm） column was used, the mobile phase was 0.25 mol.L^-1 sodium dihydrogen phosphate solution （adjust pH 3.0 with phosphate）, the flow rate was 0.35 ml.min^-1. detection wavelength was at 205 nm. Result： The calibration curves of glycine and eysteine hydroehloride were linear within the range of 0.20 - 3.20mg.ml^-1 （ r = 0. 999 7 ） and 0.01 - 0.16 mg.ml^-1 （ r = 0. 999 1 ） respectively, the average recoveries （ n = 9 ） of glycine and eysteine were 99.1% and 101.9% with RSD 0, 6% and 0.9% ,respectively. Conclusion： This method is simple, aceurate and repeatable. It can be used for the quality control of compound glyeyrrhizin injection