反向高效液相色谱法同时测定复方氨酚烷胺片中三种主要组分的含量  

Contents of three main components in compound aminphenamine tablets were determined simultaneously by reverse phase high-performance liquid chromatography

作　　者：杨旭 张蕊 YANG Xu;ZHANG Rui(Chemical Room,Jilin Institute for Drug Control,Jilin Province,Changchun130033,China)

机构地区：[1]吉林省药品检验研究院化学室,吉林长春130033

出　　处：《中国当代医药》2023年第3期61-64,共4页China Modern Medicine

摘　　要：目的建立复方氨酚烷胺片中三种主要组分含量测定的反向高效液相色谱(RP-HPLC)法。方法色谱柱选用ZORBAX Eclipse XDB-C18色谱柱(4.6 mm×150 mm,5μm),流动相选用85∶15的戊烷磺酸钠-甲醇溶液(0.05 mol/L),流速及柱温分别设置为1.0 ml/min、30℃,检测波长选取216 nm,进样量设定20μl,进样测定复方氨酚烷胺片中马来酸氯苯那敏、对乙酰氨基酚、咖啡因的含量,并进行方法学考察。结果马来酸氯苯那敏在2.25~42.90 mg/L浓度范围内呈良好的线性关系(r=0.9971),对乙酰氨基酚在30.10~526.71 mg/L浓度范围内呈良好的线性关系(r=0.9983),咖啡因在4.50~96.82 mg/L浓度范围内呈良好的线性关系(r=0.9989)。马来酸氯苯那敏、对乙酰氨基酚、咖啡因的加样回收率为分别为98.49%(RSD=0.844%)、99.39%(RSD=0.607%)、99.70%(RSD=0.159%)。结论应用RP-HPLC测定复方氨酚烷胺片中三种主要组分的含量,具有较好的准确性和重现性,且方法简单迅速,可用于其主要组分的含量测定及质量控制。Objective To establish a reverse phase high-performance liquid chromatography(RP-HPLC)method for determining the content of three main components in compound aminophamine tablets.Methods ZORBAX Eclipse XDB-C18 column(4.6 mm×150 mm,5μm),85∶15 sodium pentane-methanol solution(0.05 mol/L),flow rate and column temperature were set to 1.0 ml/min,30℃,detection wavelength selected 216 nm,sample intake set 20 L.The contents of Chlorpheniramine Maleate,Acetaminophen and Caffeine in compound aminophenidamine tablets were determined and investigated methodologically.Results Chlorpheniramine Maleate showed a good linear relationship(r=0.9971)ranging from 2.25-42.90 mg/L,Acetaminophen in the 30.10-526.71 mg/L concentration range(r=0.9983),and Caffeine in the 4.50-96.82 mg/L concentration range(r=0.9989).The recovery rates of Chlorpheniramine Maleate,Acetaminophen and Caffeine were 98.49%(RSD=0.844%),99.39%(RSD=0.607%),99.70%(RSD=0.159%),respectively.Conclusion Using RP-HPLC to determine the content of the three main components of good accuracy and reproducibility,and can be used for its content determination and quality control.

关 键 词：复方氨酚烷胺 反向高效液相色谱法 含量 马来酸氯苯那敏 对乙酰氨基酚 咖啡因 

分 类 号：R927.2[医药卫生—药学]