高效液相色谱法测定盐酸精氨酸葡萄糖注射液中盐酸精氨酸的含量

Assay of arginine hydrochloride in arginine hydrochloride and glucose injection by HPLC

目的建立测定盐酸精氨酸葡萄糖注射液中盐酸精氨酸含量的方法。方法使用高效液相色谱法,色谱条件为:Shim-Pack-CLC-NH2柱;流动相为乙腈-磷酸盐缓冲液(50:50);流速为1 ml/min;检测波长为200 nm。结果线性范围为0.04-0.2 mg/ml;相关系数R=0.999 8;回收率为99.9%(RSD=0.30%,n=9)。结论此方法重复性好,结果准确,可用于测定盐酸精氨酸葡萄糖注射液中盐酸精氨酸的含量。

Objective To establish the high Performance Iiquid Chromatography（HPLC） method to determine the content of arginine hydrochloride in arginine hydrochloride and glucose injection. Methods HPLC analysis was carried out with mobile phase acetonitrile-phosphate buffer solution（50：50） and flow rate 1.0 ml/min on Shim-Pack-CLC-NH2 column（250 mm × 4.6 mm）. Detecting wavelength was 200 nm. Results The linear range of arginine hydrochloride was 0.04-0.2 mg/ml with the correlation coefficient 0.9998. The average recovery rate was 99.9% with the relative standard deviation RSD 0.30%（n=9）. Conclusion The method is accurate and hepeatable and can be used to the assay of arginine hydrochloride in arginine hydrochloride and glucose injection.