氨咖愈敏溶液中对乙酰氨基酚、愈创甘油醚、咖啡因、马来酸氯苯那敏含量测定方法的研究

目的研究分析氨咖愈敏溶液含量测定方法，优化色谱分离条件。方法采用C18柱，流动相为磷酸二氢铵溶液-乙腈-甲醇（70：10：20），检测波长为271nm，测定对乙酰氨基酚、愈创甘油醚、无水咖啡因含量；采用C18柱，流动相为磷酸二氢铵缓冲液（0．1％三乙胺）-乙腈（73：27），检测波长为221nm，测定马来酸氯苯那敏含量。结果对乙酰氨基酚、愈创甘油醚、咖啡因分别在0．03051～0．3051mg／ml（r=1）、0．009748～0．09748mg／ml（r=1）、0．003838～0．03838mg／ml（r=1）与峰面积有良好的线性关系，平均回收率分别为101．5％、100．6％、100．7％（n=9），马来酸氯苯那敏在0．003968～0．03968mg／m]（r=1）与峰面积有良好的线性关系，平均回收率为100．1％（n=9）。结论该方法操作简便、准确、重复性好，可用于氨咖愈敏溶液的质量控制。

Study on the contents of paracetamol,guaifenesin, caffeine,chlorphenamine maleate in paracetamol caffeine guaifenfsin and chorphenamine maleate solution

Objective To study the contents determination of paracetamol caffeine guaifenfsin and chorphenamine maleate solution, and optimize the chromatographic condition. Methods To determine paracetamol, guaifenesin, and caffeine, analysis was performed on a Cis column with mobile phase consisting of methanol-acetoitrile-ammonium dihydrogen phosphate-（20：10：70） and the wavelength was 271 nm. To determine chlorphenamine maleate, analysis was performed on a Cls column with mobile phase consisting of acetoitrile-ammonium dihydrogen phosphate-triethylamine （27：73：0.1） and the wavelength was 221 nm. Results The linear calibration curves for paracetamol, guaifenesin, caffeine, and chlorphenamine maleate were obtained in the concentration range of 0.030 51-0.3051 mg/ml （r=1）, 0.009 748-0.097 48 mg/ml（r=1）, 0.003 838-0.038 38 mg/ml（r=1）, 0.003 968-0.039 68 mg/ml （r=1） respectively. The average recoveries（n=9） were 101.5%, 100.6%, 100.7%, and 100.1% respectively. Conclusion A simple, accurate, and reproducible high performance liquid chromatography method is developed. The method is fully validated and could be successfully applied to the quality control of paraeetamol caffeine guaifenfsin and chorphenamine maleate solution