HPLC法测定硫酸阿托品滴眼液中4种常用抑菌剂的含量
Determination of Four Common Bacteriostatic Agents in Atropine Sulfate Eye Drops by HPLC
谭英 1李昭 2李晓燕 3盛忻 1马晓宁 2易必新 3兰文 2刘雁鸣 2石笑弋2
作者信息
- 1. 湖南省药品检验检测研究院,湖南长沙 410001
- 2. 湖南省药品检验检测研究院,湖南长沙 410001;国家药品监督管理局药用辅料工程技术研究重点实验室,湖南长沙410001
- 3. 湖南省药品审核查验中心,湖南长沙 410001
- 折叠
摘要
目的 建立反向高效液相色谱法同时测定硫酸阿托品滴眼液中4种常用抑菌剂(4-羟基苯甲酸、苯甲酸、苯甲醇、山梨酸)的含量.方法 应用RP-HPLC等度洗脱法,采用C18色谱柱(250 mm×4.6 mm,5 µm),以0.05 mol·L-1磷酸二氢钾溶液(含0.0025 mol·L-1庚烷磺酸钠)-乙腈(84:16)(用三乙胺调节pH值至5.0)为流动相,检测波长为225 nm,流速为1.0 mL·min-1,柱温30 ℃.结果 在该色谱条件下,主成分峰与各抑菌剂完全分离,滴眼液中基质无干扰;方法重复性良好、稳定性良好;4种抑菌剂在各自浓度范围内具有良好的线性关系.结论 本法专属性、重复性良好,结果稳定,可用于硫酸阿托品滴眼液中四种常用抑菌剂含量的检测.
Abstract
OBJECTIVE To determine the content of four common bacteriostatic agents(4-hydroxybenzoic acid,benzoic acid,benzyl alcohol,and benzoic acid)in atropine sulfate eye drops by RP-HPLC.METHODS The separation was performed on a C18 column(4.6 mm ×250 mm,5 μm)with isometric elution.The mobile phase was composed of 0.05 mol·L-1 potassium dihydrogen phosphate solution(containing 0.0025 mol·L-1 heptane sodium sulfonate,adjusting pH value to 5.0 with triethylamine)-acetonitrile(90:10);The flow rate was 1.0 mL·min-1.The column temperature was 30 ℃ and the detection wavelength was 225 nm.RESULTS Under the selected chro-matographic conditions,it could separate four common bacteriostatic agents from main drug and formulation excipients without interference.The repeatability and stability of the method were good.The excellent linear behaviors over the investigated concentration ranges were observed.CONCLUSION The method is specific and repeatable,and the results are stable,it can be used for the detection of four common bacteriostatic agents in atropine sulfate eye drops.
关键词
硫酸阿托品/高效液相色谱法/抑菌剂/4-羟基苯甲酸、苯甲酸、苯甲醇、山梨酸Key words
Atropine sulfate/High-performance liquid chromatography/Bacteriostatic agent/4-hydroxybenzoic acid/Benzoic acid/Benzyl alcohol/Benzoic acid引用本文复制引用
出版年
2024
NETL
NSTL
万方数据