反相高效液相色谱法测定酚氨咖敏片的含量及其均匀度  

Determination of Content and Content Uniformity of Paracetamol,Aminophenazone Caffeine and Chlorphenamine Maleate Tablets by RP-HPLC

作　　者：王丽琼 Wang Liqiong(Leshan Food and Drug Inspection Center,Leshan,Sichuan,China 614000)

机构地区：[1]四川省乐山市食品药品检验检测中心,四川乐山614000

出　　处：《中国药业》2018年第4期16-19,共4页China Pharmaceuticals

摘　　要：目的建立同时测定酚氨咖敏片4种组分含量的高效液相色谱(HPLC)法,考察咖啡因和马来酸氯苯那敏的含量均匀度。方法色谱柱采用XTerra~ RP_18柱(250 mm×4.6 mm,5μm),以甲醇为流动相A,0.02 mol/L磷酸二氢钾溶液-三乙胺(100∶0.02)为流动相B,梯度洗脱,流速为1.0 mL/min,柱温为30℃,检测波长为215 nm。结果酚氨咖敏片中氨基比林、对乙酰氨基酚、咖啡因和马来酸氯苯那敏的分离度均符合要求,质量浓度线性范围分别为100.26~1 002.60μg/mL(r=0.999 8),149.85~1 498.50μg/mL(r=0.998 9),29.98~299.80μg/mL(r=0.999 8),2.16~21.61μg/mL(r=0.999 8);平均加样回收率分别为98.98%,98.89%,99.38%,100.48%,RSD分别为1.38%,1.07%,1.27%,1.25%(n=6)。结论该方法简便,快速,准确,适用于酚氨咖敏片的含量及其均匀度测定,有利于质量控制。Objective To establish an HPLC method for simultaneous determination of 4 components in Paracetamol,Aminophenazone Caffeine and Chlorphenamine Maleate Tablets,and to investigate content uniformity of caffeine and chlorphenamine maleate.Methods XTerra○R RP18 column(250 mm×4.6 mm,5μm)was adopted with gradient elution of methanol(mobile phase A)and 0.02 mol/L potassium dihydrogen phosphate-triethylamine(100∶0.02,mobile phase B)at the flow rate of 1.0 mL/min,the column temperature was 30℃,and the detection wavelength was 215 nm.Results The resolution of aminopyrine,paracetamol,caffeine and chlorphenamine maleate in Paracetamol,Aminophenazone Caffeine and Chlorphenamine Maleate Tablets met the requirements,and the linear ranges were 100.26-1002.60μg/mL(r=0.9998),149.85-1498.50μg/mL(r=0.9989),29.98-299.80μg/mL(r=0.9998)and 2.16-21.61μg/mL(r=0.9998),respectively.The average recoveries were 98.98%,98.89%,99.38%and 100.48%,and RSD s were 1.38%,1.07%,1.27%,1.25%(n=6).Conclusion The method is simple,rapid,accurate and suitable for the content and uniformity determination of Paracetamol,Aminophenazone Caffeine and Chlorphenamine Maleate Tablets,which is conducive to the quality control.

关 键 词：酚氨咖敏片 氨基比林 对乙酰氨基酚 咖啡因 马来酸氯苯那敏 反相高效液相色谱法 含量 含量均匀度 

分 类 号：R927.2[医药卫生—药学] R917