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

作　　者：王皖 罗时 陈鸿玉 王晓菲 彭飞城 李钰鑫 WANG Wan;LUO Shi;CHEN Hongyu;WANG Xiaofei;PENG Feicheng;LI Yuxin(Hunan Institute for Drug Contrl,Changsha 410001,China;Hunan Drug Inspection Center,Changsha 410001,China)

机构地区：[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

出　　处：《中国药师》2024年第4期545-550,共6页China Pharmacist

基　　金：2023年国家药品抽检计划项目。

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10.596~211.920μg/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1.027~20.540μg/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。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,5µm)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 25µL.Results Sodium metabisulfite showed good linearity(r=0.9993)in the range of 10.596-211.920µg/mL,and its average recovery rate was 100.00%,with an RSD of 1.4%(n=9).Sodium sulfate showed good linearity(r=0.9998)in the range of 1.027-20.540μg/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 

分 类 号：R927.2[医药卫生—药学]