离子色谱法测定药品中抗坏血酸

Determination of ascorbic acid in pharmaceuticals by ion chromatography

建立离子色谱法测定药品中抗坏血酸含量的方法。以SH-AC-3型阴离子交换柱为分离柱,以12.0 mmol/LNaHCO溶液为淋洗液,流量为1.0 mL/min,柱温为30℃,采用等度洗脱的方式将抗坏血酸与氟化物、氯化物、亚硝酸盐、溴化物、硝酸盐、磷酸盐和硫酸盐等常见阴离子完全分离,通过抑制电导检测器检测,色谱峰面积标准曲线法定量。抗坏血酸的色谱峰面积与其质量浓度在3.0~500.0 mg/L范围内线性关系良好,相关系数为0.9993,方法检出限为2.7 mg/L。该方法用于维生素C针剂和片剂中抗坏血酸含量的测定,样品加标回收率为95.1%~101.6%,5次平行测定结果的相对标准偏差为1.55%~2.79%(n=5)。该方法操作简便,检测快速,可用于维生素C针剂和片剂中抗坏血酸含量的测定。

A method for determining ascorbic acid by ion chromatography was developed.SH-AC-3 anion exchange column was used as separation column,12.0 mmol/L NaHCOsolution was used as eluent with the flow rate of 1.0 mL/min and the column box temperature of 30℃,ascorbic acid was able to be completely separated from common anions such as fluoride,chloride,nitrite,bromides,nitrate,phosphate and sulfate by isometric elution,and then was detected by inhibiting conductance.The mass concentration of ascorbic acid had a good linear relationship with the chromatographic peak area in the range of 3.0-500.0 mg/L,the correlation coefficient was 0.9993,and the detection limit of the method was 2.7 mg/L.The method was applied to the determination of ascorbic acid in vitamin C injections and tablets,the recoveries were 95.1%-101.6%,the relative standard deviations were 1.55%-2.79%(n=5).The method was simple and rapid,and it can be used for the determination of ascorbic acid in vitamin C injection and tablet.