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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 for the determination of chlorine in arginine hydrochloride injection. METHODS: The column was anion exchange column HAMILTON PRPX100 (4.1 mm × 250 mm, 10 μm). With 0.1 mol·L-1 potassium nitrate solution 1000 mL, methanol 500 mL and 0.1 mL tetrabutylammonium hydroxide (10%), then add water to 5 000 mL as the mobile phase at a flow rate of 1.0 mL · min-1. The detection wavelength is 240 nm and the column temperature is 35 ℃. The injection volume is 100 μL. Results: The linearity was good (r = 0.999 9) and the average recovery (n = 9) was 99.1% with the concentration of Cl-1 in the range of 0.034-0.272 mg · m L-1. The precision, repeatability and stability All meet the requirements. The determination results of 81 samples of chlorine were 16.2% ~ 17.6%. Conclusion: This method is validated by methodology, and can be used as a method for quality control of chlorine content in arginine hydrochloride injection.