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 Sulf ate Eye Drops by HPLC

作　　者：谭英 李昭 李晓燕 盛忻 马晓宁 易必新 兰文 刘雁鸣 石笑弋 TAN Ying;LI Zhao;LI Xiao-yan;SHENG Xin;MA Xiao-ning;YI Bi-xin;LAN Wen;LIU Yan-ming;SHI Xiao-yi(Hunan Institute for Drug Control,Changsha 410001,China;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,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,湖南长沙410001 [2]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

出　　处：《海峡药学》2024年第9期38-41,共4页Strait Pharmaceutical Journal

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C_(18)色谱柱(250 mm×4.6 mm,5μm),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。OBJECTIVE To determine the content of four common bacteriostati c agents(4-hydroxybenzoic acid,benzoic acid,benzyl alcohol,and benzoic acid)in atropine sulfate eye drops by RP-HPLC.METHODS The separ ation was performed on a C 18 column(4.6 mm×250 mm,5μm)with isometri c elution.The mobile phase was composed of 0.05 mol·L^(-1)potassium dihyd rogen phosphate solution(containing 0.0025 mol·L^(-1)heptane sodium sulfo nate,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 th e de tection wavelength was 225 nm.RESULTS Under the selected chrom atographic 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 inve stigated concentration ranges were observed.CONCLUSION The met hod is specific and repeatable,and the results are stable,it can be used for t he 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 

分 类 号：R927[医药卫生—药学]