HPLC法同时测定依巴斯汀口服溶液中抑菌剂及其降解产物  

HPLC was Used to Simultaneously Determine the Bacteriostatic Agent and Its Degradation Products in Ebastine Oral Solution

作　　者：李昭 石笑弋 彭飞城 李晓燕 谭英 郑金凤 刘雁鸣 刘航宇 吴琦琦 Li Zhao;Shi Xiaoyi;Peng Feicheng;Li Xiaoyan;Tan Ying;Zheng Jinfeng;Liu Yanming;Liu Hangyu;Wu Qiqi(Hunan Institute for Drμg Control,Changsha 410001,China;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Changsha 410001,China;Hunan Drμg Inspection Center,Changsha 410001,China;Hunan Traditional Chinese Medicine College,Changsha 412000,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 [4]湖南中医药高等专科学校,湖南长沙412000

出　　处：《广东化工》2024年第15期135-137,共3页Guangdong Chemical Industry

摘　　要：目的:建立同时测定依巴斯汀口服溶液中羟苯甲酯钠、羟苯丙酯钠两种抑菌剂及其降解产物对羟基苯甲酸含量的HPLC法。方法:色谱柱:Diamonsil C18柱(250 mm*4.6 mm,5μm),流动相:甲醇-1%冰醋酸溶液(58:42),流速:1.0 mL/min,柱温:40℃,检测波长:254 nm,进样量:20μL。结果:各色谱峰分离度良好;阴性样品无干扰;对羟基苯甲酸在0.3391 mg/mL~3.3912 mg/mL范围内线性关系良好(r=0.9997),羟苯甲酯钠在4.8565 mg/mL~48.5654 mg/mL范围内线性关系良好(r=0.9997),羟苯丙酯钠1.2004 mg/mL~12.0043 mg/mL范围内线性关系良好(r=0.9995);对羟基苯甲酸、羟苯甲酯钠、羟苯丙酯钠平均回收率分别为99.71%(RSD:0.95%,n=12)、99.82%(RSD:0.35%,n=9)、100.65%(RSD:0.75%,n=9);精密度、重复性、稳定性试验结果良好。结论:该方法操作简便,结果准确,稳定性好,可用于同时测定依巴斯汀口服溶液中羟苯甲酯钠、羟苯丙酯钠两种抑菌剂及其降解产物对羟基苯甲酸的含量。Objective:A high-performance liquid chromatography method was established for the simultaneous determination of the content of two bacteriostatic agents,sodium methylparaben and sodium propylparaben and their degradation products,p-hydroxybenzoic acid,in ebastine oral solution.Methods:The chromatographic column was Diamonsil C18 column(250 mm*4.6 mm,5μm),the mobile phase was methanol-1%glacial acetic acid solution(58∶42),the flow rate was 1.0 mL/min,the column temperature was 40℃,the detection wavelength was 254 nm,and the injection volume was 20μL.Results:The separation of the peaks of p-hydroxybenzoic acid,methylparaben and propylparaben was good,there was no interference in the negative samples,and the linear relationship between p-hydroxybenzoic acid in the range of 0.3391 mg/mL~3.3912 mg/mL was good(r=0.9997),the linear relationship between sodium methylparaben was good in the range of 4.8565 mg/mL~48.5654 mg/mL(r=0.9997),and the linear relationship between propylparaben was good in the range of 1.2004 mg/mL~12.0043 mg/mL(r=0.9995).The average recoveries of p-hydroxybenzoic acid,sodium methylparaben and sodium propylparaben were 99.71%(RSD:0.95%,n=12),99.82%(RSD:0.35%,n=9)and 100.65%(RSD:0.75%,n=9),respectively,and the test results of precision,repeatability and stability were good.Conclusion:This method is easy to operate,the results are accurate and the stability is good,and it can be used to determine the content of p-hydroxybenzoic acid in the two bacteriostatic agents and their degradation products in ebastine oral solution.

关 键 词：依巴斯汀口服溶液 高效液相色谱法 抑菌剂 对羟基苯甲酸 羟苯甲酯钠 羟苯丙酯钠 

分 类 号：R927.2[医药卫生—药学]