离子色谱法测定甲磺酸酚妥拉明注射液中焦亚硫酸钠及硫酸钠的含量
Content determination of sodium pyrosulfite and sodium sulphate in phentolamine mesylate injection by ion chromatography
王皖 1罗时 2陈鸿玉 1王晓菲 1彭飞城 1李钰鑫1
作者信息
- 1. 湖南省药品检验检测研究院(长沙 410001)
- 2. 湖南省药品审核查验中心(长沙 410001)
- 折叠
摘要
目的 建立测定甲磺酸酚妥拉明注射液中焦亚硫酸钠及硫酸钠含量的方法.方法 采用离子色谱法,色谱柱为DionexIonPac AS11-HC柱(250 mm × 4.0 mm,5μm),以氢氧化钾溶液为淋洗液,梯度洗脱,流速为1.0 mL/min,柱温为30 ℃,进样体积为25μL.结果 焦亚硫酸钠在10.596～211.920 μg/mL范围内线性关系良好(r=0.999 3),平均回收率100.00％(RSD=1.4％,n=9);硫酸钠在1.027～20.540 μg/mL之间线性关系良好(r=0.999 8),平均回收率99.96％(RSD=1.8％,n=9).结论 建立的方法简便、准确、灵敏度高,适用于甲磺酸酚妥拉明注射液中焦亚硫酸钠及硫酸钠含量的测定.
Abstract
Objective To establish a method for the determination of contents of sodium metabisulfite and sodium sulfate in phentolamine mesylate injection.Methods The ion chromatography method with a DionexIonPac AS11-HC(250 mm×4.0 mm,5 pm)column was used,with potassium hydroxide solution as eluent,gradient elution,flow rate of 1.0 mL/min.The column temperature was 30 ℃ and the injection volume was 25 μL.Results Sodium metabisulfite showed good linearity(r=0.999 3)in the range of 10.596-211.920 μg/mL,and its average recovery rate was 100.00％,with an RSD of 1.4％(n=9).Sodium sulfate showed good linearity(r=0.999 8)in the range of 1.027-20.540 μg/mL,and its average recovery rate was 99.96％,with an RSD of 1.8％(n=9).Conclusion The established method is simple,accurate,sensitive and suitable for the determination of sodium metabisulfite and sodium sulfate contents in phentolamine methylate injection.
关键词
离子色谱法/甲磺酸酚妥拉明注射液/焦亚硫酸钠/硫酸钠/含量测定Key words
Ion chromatography/Phentolamine mesylate injection/Sodium metabisulfite/Sodium sulfate/Content determination引用本文复制引用
出版年
2024
NETL
NSTL
万方数据