阴离子交换色谱法测定盐酸精氨酸注射液中氯的含量

Determination of chlorine( Cl) in arginine hydrochloride injection with anion- exchange chromatography

目的：建立阴离子交换色谱法测定盐酸精氨酸注射液中氯的含量。方法：色谱柱为阴离子交换柱HAMILTON PRPX100（4.1 mm×250 mm,10μm）,以0.1 mol·L-1硝酸钾溶液1 000 m L,加甲醇500 m L和0.1 m L氢氧化四丁基铵溶液（10%）,然后加水至5 000 m L为流动相,流速1.0 m L·min-1,检测波长240nm,柱温35℃,进样量100μL。结果：Cl-1质量浓度在0.034～0.272 mg·m L-1范围内,线性关系良好（r=0.999 9）,平均回收率（n=9）为99.1%,精密度、重复性、稳定性均符合要求。81批样品氯的测定结果为16.2%～17.6%。结论：本法经方法学验证,可作为盐酸精氨酸注射液中氯含量质量标准控制的方法。

Objective： To establish an anion- exchange chromatography method for chlorine（ Cl） determination in arginine hydrochloride injection. Methods： HAMILTON PRP- X100 Anion Exchange（ 4. 1 mm × 250 mm,10 μm）column was adopted for the study. The mobile phase was prepared with 1 000 m L 0. 1 mol·L- 1potassium nitrate,500 m L methyl and 0. 1 m L tetrabutylam monium hydroxid solution（ 10%）,then added water to 5 000 m L,with a flow rate at 1. 0 m L·min- 1. The detection wavelength was 240 nm,and the column temperature was 35 ℃. The injection volume was 100 μL. Results： Chlorine（ Cl） showed a good linear relationship within the range of 0. 034-0. 272 mg·m L- 1（ r = 0. 999 9）,and the average recovery（ n = 9） was 98. 8%. Precision,repeatability,and stability can be accomplished with the requirements. The determined chlorine of 81 batches of samples was arranged between 16. 2%-17. 6% 。Conclusion： The established method can be used for the quality control of chlorine（ Cl） in arginine hydrochloride injection.