阴离子交换色谱法测定盐酸精氨酸注射液中氯的含量

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 PRP-X100(4.1 mm×250 mm,10 μm),以0.1 mol·L^-1硝酸钾溶液1 000 mL,加甲醇500 mL和0.1 mL氢氧化四丁基铵溶液(10%),然后加水至5 000 mL为流动相,流速1.0 mL·min^-1,检测波长240nm,柱温35 ℃,进样量100 μL。结果: Cl^-1质量浓度在0.034~0.272 mg·mL^-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 mL 0.1 mol·L^-1 potassium nitrate, 500 mL methyl and 0.1 mL tetrabutylam monium hydroxid solution(10%), then added water to 5 000 mL, with a flow rate at 1.0 mL·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·mL^-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.

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