高效液相色谱法同时测定氨咖愈敏溶液中4种成分含量  

Simultaneous Determination of Four Components in Paracetamol,Caffeine,Guaifenesin and Chlorphenamine Maleate Solution by HPLC

作　　者：梁爱仙 庞发根 刘敏 李玉兰 LIANG Aixian;PANG Fagen;LIU Min;LI Yulan(Shenzhen Institute for Drug Control,Shenzhen Key Laboratory of Drug Quality Standard Research,Shenzhen,Guangdong,China 518057)

机构地区：[1]广东省深圳市药品检验研究院·广东省深圳市药品质量标准研究重点实验室

出　　处：《中国药业》2019年第16期29-31,共3页China Pharmaceuticals

摘　　要：目的建立同时测定氨咖愈敏溶液中对乙酰氨基酚、咖啡因、愈创木酚甘油醚和马来酸氯苯那敏含量的高效液相色谱(HPLC)法。方法采用DiamonsilC18柱(250mm×4.6mm,5μm),流动相为磷酸三乙胺缓冲液(取三乙胺3.0mL,加水至1000mL,用磷酸调pH至2.6)-乙腈(85∶15,V/V),流速1.0mL/min,检测波长264nm,柱温40℃,进样量20μL。结果对乙酰氨基酚、咖啡因、愈创木酚甘油醚和马来酸氯苯那敏质量浓度线性范围分别为4.816~240.800μg/mL,3.808~190.400μg/mL,3.816~190.800μg/mL,2.226~111.300μg/mL(r>0.9990),平均回收率为99.88%~100.66%,RSD为0.48%~1.20%(n=9);精密度、稳定性、重复性试验的RSD均小于2%。结论该方法简便、快速、准确,精密度、稳定性、重复性均较好,可用于同时测定氨咖愈敏溶液中4种成分的含量。Objective To establish an HPLC method for simultaneous determination of paracetamol,caffeine,guaifenesin and chlorphenamine maleate in Paracetamol,Caffeine,Guaifenesin and Chlorphenamine Maleate Solution. Methods The chromatographic column was Diamonsil C18 column( 250 mm × 4. 6 mm,5 μm),the mobile phase was triethylamine phosphate buffer( added water to 3. 0 mL of trimethylamine to 1 000 mL,adjusted pH to 2. 6 with phosphoric acid)-acetonitrile( 85 ∶ 15,V/V),the flow rate was 1. 0 mL/min,the detection wavelength was 264 nm,the column temperature was 40 ℃ and the sample size was 20 μL. Results The paracetamol,caffeine,guaifenesin and chlorphenamine maleate showed good linear relationship with peak area in the ranges of 4. 816-240. 800 μg/mL,3. 808-190. 400 μg/mL,3. 816-190. 800 μg/mL and 2. 226-111. 300 μg/mL( r > 0. 999 0),the average recovery was in the range of 99. 88%-100. 66% and the RSD was in the range of 0. 48%-1. 20%( n = 9). Conclusion The method is simple,rapid and accurate with good precision and repeatability. It can be used for the simultaneous determination of four components in Paracetamol,Caffeine,Guaifenesin and Chlorphenamine Maleate Solution.

关 键 词：高效液相色谱法 氨咖愈敏溶液 含量测定 对乙酰氨基酚 咖啡因 愈创木酚甘油醚盐酸 马来酸氯苯那敏 质量控制 

分 类 号：R917[医药卫生—药物分析学] R927.2[医药卫生—药学]