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目的:建立测定维生素B1注射液中EDTA及硝酸根离子含量的离子色谱法。方法:采用IonPac AS 11-HC色谱柱(4.0 mm×250 mm),IonPac AS 11-HC guard保护柱(4.0 mm×50 mm)和ASRS 300抑制器(4 mm),淋洗液为12 mmol·L-1氢氧化钠,流速1.0 mL·min-1,抑制电流60 mA,电导检测器温度35℃,柱温30℃,进样体积25μL。结果:EDTA和硝酸根离子检出限分别为0.29,0.01 mg·L-1,EDTA在1.19~23.8 mg·L-1,线性关系良好(r=0.999 7),回收率为98.2%~100.6%;硝酸根离子在1.0~10.0 mg·L-1线性关系良好(r=0.999 6),回收率为97.9%~99.5%。结论:该实验方法选择性高,灵敏度好,测定结果准确,并且简便,快速,可用于注射液中ETDA及硝酸根离子的测定研究和质量控制。
Objective: To establish an ion chromatography method for the determination of EDTA and nitrate ion in vitamin B1 injection. Methods: IonPac AS 11-HC (4.0 mm × 250 mm), IonPac AS 11-HC guard column (4.0 mm × 50 mm) and ASRS 300 suppressor (4 mm) were used. L-1 sodium hydroxide at a flow rate of 1.0 mL · min-1, a current suppression of 60 mA, a conductance detector temperature of 35 ° C. and a column temperature of 30 ° C. with a sample volume of 25 μL. Results: The detection limits of EDTA and nitrate were 0.29,0.01 mg · L-1, EDTA was 1.19 ~ 23.8 mg · L-1, the linearity was good (r = 0.999 7) and the recoveries were 98.2% ~ 100.6% The linearity of nitrate ion was 1.0 ~ 10.0 mg · L-1 (r = 0.999 6). The recovery rate was 97.9% -99.5%. Conclusion: The experimental method has high selectivity, good sensitivity, accurate determination results, and is simple, rapid and can be used for the determination and quality control of ETDA and nitrate ions in injection.