摘要
目的建立离子色谱法测定阿洛西林钠中钠离子含量,通过考察不同企业样品的成盐率,对该品种的成盐工艺质量控制进行评价。方法采用IonPac CS-12A阳离子交换色谱柱(4×250 mm)和IonPac CG-12A保护柱(4×50 mm),20 mmol·L^(-1)甲烷磺酸溶液为流动相,流速1.0 mL·min^(-1),抑制器电流为65mA。结果钠离子在浓度5~15μg·mL^(-1)范围内与峰面积呈良好的线性关系,r=0.9999(n=5),平均回收率为102.9%(RSD=2.1%,n=9),测定九个厂家共100批注射用阿洛西林钠的成盐率均在97.9%~107.0%之间。结论本方法可用于阿洛西林钠的钠离子测定,各企业产品的成盐率工艺控制较稳定。
OBJECTIVE To establish an ion chromatographic method to determine the content of sodium ion and salt-forming rate in Azlocillin Sodium.According to the method,the salt formation process of different enterprises were evaluated.METHODS A column of IonPac CS-12A(4×250 mm)and a protect column of IonPac CG-12A(4×50 mm)were used.20 mmol·L^(-1)of MSA solution as the mobile phase.The flow rate was 1.0 mL·min^(-1) and the suppressor current value was set as 65 mA.RESULTS The linear range was 5-15μg·mL^(-1),r=0.9999(n=5),the average recovery rate was 102.9%(RSD=2.1%,n=9).The salt-forming rate of 100 batches of Azlocillin sodium for injection provided by nine manufacturers were between 97.9%-107.0%.CONCLUSION This method can be used for the sodium ion determination of Azlocillin sodium,and the process control of the salt-formation rate of the products of various enterprises is relatively stable.
作者
陈茜
伍雯琦
高丹玲
CHEN Qian;WU Wen-qi;GAO Dan-ling(Fujian Institute for Food and Drug Quality Control,Fuzhou 350001,China)
出处
《海峡药学》
2021年第11期77-80,共4页
Strait Pharmaceutical Journal
关键词
离子色谱
电导检测器
阿洛西林钠
钠离子
成盐率
Ionchromatography
Conductivity detector
Azlocillin Sodium
Sodium ion
Salt-forming rate
