氨咖黄敏胶囊中对氨基酚和对氯苯乙酰胺的检测  

Determination of P-aminophenol and P-chloracetanilide in Paracetamol Caffein,Atificial Cow-bezaoar and Chlorphenamine Maleate Capsules

作　　者：刘志辉 赖锴然 LIU Zhi-hui;LAI Kai-ran(The Food and Drug Control of Meizhou Institute,Guangdong Meizhou 514071,China;Jiaying College Medical College,Guangdong Meizhou 514071,China)

机构地区：[1]梅州市食品药品监督检验所,广东梅州514071 [2]嘉应学院医学院,广东梅州514071

出　　处：《中国药物评价》2019年第2期120-122,129,共4页Chinese Journal of Drug Evaluation

摘　　要：目的:建立氨咖黄敏胶囊中对氨基酚和对氯苯乙酰胺的HPLC测定方法。方法:色谱柱:Accerasil C8(4. 6 mm×250mm,5μm);流动相:甲醇-磷酸盐缓冲液(磷酸氢二钠8. 95 g,磷酸二氢钠3. 9 g,加水溶解至1 000 mL,加10%四丁基氢氧化铵溶液12 mL),梯度洗脱;流速0. 8 mL·min^(-1);检测波长为240 nm;柱温35℃;进样量20μL。结果:对氨基酚浓度在0. 100 5～30. 15μg·mL^(-1)、对氯苯乙酰胺浓度在0. 096 6～11. 59μg·mL^(-1)范围内与峰面积线性关系良好(r≥0. 999 7),检测限分别为0. 17 ng、0. 14 ng,平均回收率分别为101. 60%、99. 05%(RSD≤0. 7%n=9)。结论:该方法专属性好、操作简便、快速准确,可用于氨咖黄敏胶囊中对氨基酚和对氯苯乙酰胺的检测,可为提高该药的质量控制技术提供参考。Objective:To establish an HPLC method for determination of P-aminophenol and P-chloracetanilide in Paracetamol Caffein,Atificial Cow-bezaoar and chlorphenamine Maleate capsules.Methods:The eluate obtained was analyzed by HPLC method with Accerasil C 8(4.6 mm×250 mm,5μm),phosphate buffer solution-methanol as a mobile phase gradient elution.The flow rate was 0.8 mL·min^-1.The detection wave length was 240 nm,and the column temperature was 35℃.The injection volume was 20μL.Results:P-aminophenol and P-chloracetanilide showed good linearity in the ranges of 0.100 5~30.15、0.096 6~11.59μg·mL^-1(r≥0.999 7)respectively.The detection limit were 0.17 ng、0.14 ng respectively.The average recovery values values of P-aminophenol and P-chloracetanilide of were 101.60%、99.05%(RSD≤0.7%,n=9)respectively.Conclusion:The method is simple with high accuracy and reproducible,which can be used for the determination P-aminophenol and P-chloracetanilide in Paracetamol Caffein,Atificial Cow-bezaoar and chlorphenamine Maleate capsules.

关 键 词：氨咖黄敏胶囊 对氨基酚 对氯苯乙酰胺 HPLC 梯度洗脱 

分 类 号：R927.1[医药卫生—药学]