IP-RP-HPLC法同时测定感冒清片中3种成分  

Simultaneous determination of three constituents in Ganmaoqing Tablets by IP-RP-HPLC

作　　者：朱链链[1] 王丽琼 ZHU Lian⁃lian;WANG Li⁃qiong(Leshan Vocational and Technical College,Leshan 614000,China;Leshan Food and Drug Inspection Center,Leshan 614000,China)

机构地区：[1]乐山职业技术学院,四川乐山614000 [2]乐山市食品药品检验检测中心,四川乐山614000

出　　处：《中成药》2020年第2期313-316,共4页Chinese Traditional Patent Medicine

摘　　要：目的建立离子对反相高效液相色谱(IP⁃RP⁃HPLC)法同时测定感冒清片(南板蓝根、大青叶、对乙酰氨基酚等)中3种成分的含有量。方法该药物25%甲醇提取物的分析采用Waters XTerra C18色谱柱(250 mm×4.6 mm,5μm);流动相甲醇⁃0.02 mol/L磷酸二氢钾,梯度洗脱;体积流量1.0 mL/min;柱温30℃;检测波长215 nm。然后,按照2015年版《中国药典》四部方法计算含有量均匀度。结果对乙酰氨基酚、盐酸吗啉胍、马来酸氯苯那敏分别在96.66~966.63μg/mL(r=0.9999)、95.48~954.80μg/mL(r=0.9998)、4.08~40.84μg/mL(r=1.0000)范围内线性关系良好,平均加样回收率分别为100.9%、99.5%、99.6%,RSD分别为1.2%、0.9%、1.2%。结论该方法简便、快速、准确,可用于感冒清片的质量控制。AIM To establish an ion⁃pair reverse⁃phase high performance liquid chromatography(IP⁃RP⁃HPLC)method for the simultaneous content determination of three constituents in Ganmaoqing Tablets(Baphica⁃canthis cusiae Rhizoma et Radix,Isatidis Folium,paracetamol,etc.).METHODS The analysis of 25%methanol extract of this drug was performed on a 30℃thermostatic Waters XTerra C18 column(250 mm×4.6 mm,5μm),with the mobile phase comprising of methanol⁃0.02 mol/Lpotassium dihydrogen phosphate flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 215 nm.Subsequently,the con⁃tent uniformity was calculated according to Chinese Pharmacopoeia(2015 Edition,PartⅣ)method.RESULTS Paracetamol,moroxydine hydrochloride and chlorphenamine maleate showed good linear relationships within the ranges of 96.66-966.63μg/mL(r=0.9999),95.48-954.80μg/mL(r=0.9998)and 4.08-40.84μg/mL(r=1.0000),whose average recoveries were 100.9%,99.5%and 99.6%with the RSDs of 1.2%,0.9%and 1.2%,respectively.CONCLUSION This simple,rapid and accurate method can be used for the quality control of Ganmaoqing Tablets.

关 键 词：感冒清片 对乙酰氨基酚 盐酸吗啉胍 马来酸氯苯那敏 IP⁃RP⁃HPLC 

分 类 号：R927[医药卫生—药学]