离子色谱法测定硫酸庆大霉素颗粒中的C组分  

Determination of C components in Gentamicin sulfate granules by Ion chromatrography

作　　者：王欣[1] 周继春[1] 张广伟[1] 李展[1] WANG Xin;ZHOU Jichun;ZHANG Guangwei;LI Zhan(Henan Institute for Food and Drug Control,Zhengzhou,Henan,450003P.R.China)

机构地区：[1]河南省食品药品检验所

出　　处：《华西药学杂志》2018年第6期648-651,共4页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用离子色谱法测定硫酸庆大霉素颗粒中C组分的含量。方法采用Thermo AcclaimTMAm G C18色谱柱(150mm×4. 6 mm,3μm),流动相为0. 7%三氟乙酸(含0. 025%五氟丙酸、4 m L 50%氢氧化钠,用50%氢氧化钠调p H2. 6)-乙腈(96. 5∶3. 5),流速1. 0 m L·min-1,柱后溶液为2%氢氧化钠,柱后流速0. 3 m L·min-1,柱温35℃,检测器为脉冲安培电化学检测器,工作电极为金电极(直径3 mm),检测电位为四电位。结果硫酸庆大霉素颗粒C1、C1a、C2、C2a组分的线性范围分别为1. 328~132. 8、1. 606~160. 6、7. 378~737. 8、1. 276~127. 6μg·m L-1,回收率为98. 1%~101. 9%。结论所用方法准确,可用于硫酸庆大霉素颗粒的质量控制。OBJECTIVE To determine the components of Gentamicin sulfate granules by Ion chromatrography. METHODS A Thermo AcclaimTMAm G C18( 150 mm × 4. 6 mm,3 μm) column was used with the mobile phase consisting of 0. 7% trifluoroacetic acid( 0. 025% pentafluoropropanoic acid and 4 m L of 50% sodium hydroxide solution. p H was adjusted to 2. 6 with 50% sodium hydroxide solution)-acetonitrile( 96. 5∶ 3. 5). The flow was 1. 0 m L·min-1,the post-column solution was 2% sodium hydroxide solution and the flow was 0. 3 m L·min-1 with the column temperature of 35 ℃. Pulsed amperometric detection and working electrode of gold electrode( 3 mm) were adopted with the working mode of a four potential waveform. RESULTS The linear ranges of Gentamicin C1,C1 a,C2,and C2 awere 1. 328-132. 8 μg·m L-1,1. 606-160. 6 μg·m L-1,7. 378-737. 8 μg·m L-1,and 1. 276-127. 6 μg·m L-1 respectively,and the recoveries were 98. 1%-101. 9%. CONCLUSION This method is accurate and suitable for the quality control of Gentamicin sulfate granules.

关 键 词：硫酸庆大霉素颗粒 C组分 含量测定 方法验证 离子色谱 脉冲安培电化学检测器 柱后加碱 质量控制 

分 类 号：R917[医药卫生—药物分析学]