文章摘要
曹桂红,黄春青,许波.HPLC法测定复方愈酚麻黄糖浆中愈创甘油醚和马来酸氯苯那敏[J].中国药品标准,2018,19(2):120-125
HPLC法测定复方愈酚麻黄糖浆中愈创甘油醚和马来酸氯苯那敏
Determination of Guaifenesin and Chlorphenamine maleate in compound guaifenesin giclofenac and ephedrine syrup by HPLC
投稿时间:2017-09-19  修订日期:2018-04-11
DOI:
中文关键词: 复方愈酚麻黄糖浆  愈创甘油醚  马来酸氯苯那敏  高效液相色谱法  含量测定
英文关键词: compound guaifenesin giclofenac and ephedrine syrup  Guaifenesin  Chlorphenamine maleate  HPLC  quantitative analysis
基金项目:2015年国家药品标准提高项目,项目编号:272
作者单位E-mail
曹桂红 贵州省食品药品检验所 281015351@QQ.com 
黄春青 贵州省食品药品检验所  
许波* 贵州省食品药品检验所 439207529@QQ.com 
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中文摘要:
      目的:建立测定复方愈酚麻黄糖浆中愈创甘油醚和马来酸氯苯那敏含量的高效液相色谱法(HPLC)。方法: 色谱柱为Agilent SB-C18柱(4.6mm×250 mm,5?m),流动相:乙腈- 0.02 mol?L-1磷酸二氢钾(含0.1%三乙胺,用磷酸pH至3.0)(25:75),检测波长:260nm,流速1.0mL?min-1,柱温:25℃。结果:愈创甘油醚在0.0120~1.2035?g范围内线性关系良好,回归方程Y=296882X+31351(R2=0.9998),方法回收率在99.50~ 102.82%之间(RSD在0.06~0.41%之间)(n=9),13批样品的愈创甘油醚含量在98.23~102.84%之间;马来酸氯苯那敏在0.0061~0.6055?g范围内线性关系良好,回归方程Y=752335x-921.9(R2=1.0000),方法回收率在97.70~ 98.46%之间(RSD在0.32~0.64%之间)(n=9),13批样品的马来酸氯苯那敏含量在92.39~101.22%之间;结论:该方法简便,快速,准确,可用于该制剂中愈创甘油醚和马来酸氯苯那敏的含量测定。
英文摘要:
      Objective: To establish the method of determination of guaifenesin and chlorphenamine maleate in Compound Guaifenesin Giclofenac and Ephedrine Syrup by HPLC. Methods: The test was performed in Agilent SB-C18 column with acetonitrile and 0.02mol?L-1 potassium dihydrogen phosphate solution (0.1% triethyiamine solution, adjust pH to 3.0) as mobile phase(25:75), The flow rate was 1.0 mL?min-1, the detection wavelength was 260nm, and the column temperature was 25℃. Results: The linear range fell into 0.0120-1.2035?g (R2=0.9994) the calibration equation was Y=2.969×105X+3.135×104, and the average recovery was between 99.50%- 102.82% with RSD as 0.06%-0.41% (n=9) for guaifenesin. The contents of Guaifenesin in 13 batches samples was between 98.23%- 102.84%. The linear range fell into 0.0060-0.6055?g (R2=1.0000), the calibration equation was Y=7.523×105X-921.9(R2=1.0000), and the average recovery was between 97.70%-98.46% with RSD as 0.32%-0.64% (n=9) for chlorphenamine maleate. The contents of Chlorphenamine maleate in 13 batches samples was between 92.39%-101.22%. Conclusion: This estabilished method is simple, fast and accurate. It can be used for determination of guaifenesin and chlorphenamine maleate in Compound Guaifenesin Giclofenac and Ephedrine Syrup .
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