注射用阿莫西林钠/克拉维酸钾中两组分成盐率的分析
Analysis of the salt-forming rate of two components in amoxicillin sodium and clavulanate potassium for injection
王松 1于明艳 1赵海云 1于升平 1陈德俊1
作者信息
- 1. 山东省食品药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,山东省仿制药一致性评价工程技术研究中心,济南 250101
- 折叠
摘要
目的 建立离子色谱法同时测定注射用阿莫西林钠/克拉维酸钾中钠离子与钾离子的含量,通过计算其成盐率,对不同企业样品的成盐工艺进行评价.方法 采用IonPac CS12A阳离子交换色谱柱(4 mm×250 mm)和IonPac CG12A保护柱(4 mm×50 mm),检测器为电导检测器,抑制器电流为20 mA,以6.7 mmol/L甲烷磺酸溶液为淋洗液,流速为1.0 mL/min.结果 钠离子浓度在6.01～18.04 μg/mL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100.4％(RSD=0.4％,n=9);钾离子浓度在3.33～9.98 μg/mL范围内与峰面积呈良好的线性关系(r=0.9998,n=5);平均回收率为100.2％(RSD=0.5％,n=9).测定了37批注射用阿莫西林钠/克拉维酸钾中钠和钾的含量,其成盐率分别为1.00～1.13和0.94～1.05.结论 本方法可用于注射用阿莫西林钠/克拉维酸钾中钠离子与钾离子的含量测定,各企业样品成盐情况较好,但需关注成盐剂的残留.
Abstract
Objective This research established an ion chromatographic method for simultaneous determination of sodium and potassium ions in amoxicillin sodium and clavulanate potassium for injection.According to the salt-forming rate,the salt-forming processes of different enterprises were evaluated.Methods A cation exchange chromatography column of IonPac CS-12A(4 mm×250 mm)and a protection column of IonPac CG-12A(4 mm×50 mm)were used.The detector was a suppressed conductivity detector,and the suppressor current was 20 mA.An isocratic eluent of 6.7 mmol/L of methane sulfonic acid(MSA)solution was chosen as the mobile phase,with a flow rate of 1.0 mL/min.Results The linear correlation of sodium ions was good within the range of 6.01～18.04 μg/mL(r=0.9999,n=5).The average recovery was 100.4％(RSD=0.4％,n=9).The linear correlation of potassium ions was good within the range of 3.33～9.98 μg/mL(r=0.9998,n=5).The average recovery was 100.2％(RSD=0.5％,n=9).The content of sodium and potassium ions in 37 batches of amoxicillin sodium and clavulanate potassium for injection were determined,with salt-forming rates ranging from 1.00 to 1.13 and 0.94 to 1.05,respectively.Conclusions This method could be used for the determination of sodium and potassium ions in amoxicillin sodium and clavulanate potassium for injection.The salt-forming rate of samples from various enterprises was promising,but attention should be paid to the residue of salt-forming agents.
关键词
注射用阿莫西林钠/克拉维酸钾/成盐率/离子色谱法/钠离子/钾离子Key words
Amoxicillin sodium and clavulanate potassium for injection/Salt-forming rate/Ion chromatography/Sodium ions/Potassium ions引用本文复制引用
出版年
2024
NETL
NSTL
万方数据