HPLC测定复方氨肽素片中氨茶碱与马来酸氯苯那敏的含量及含量均匀度

Content Determination and Content Uniformity Test of Aminophylline and Chlorphenamine Maleate in Compound Amino-polypeptide Tablets by HPLC

关键词:  复方氨肽素片  氨茶碱  茶碱  马来酸氯苯那敏  高效液相色谱法

Key words:  compound amino-polypeptide tablets  aminophylline  theophylline  chlorphenamine maleate  HPLC

摘要:

目的 建立HPLC测定复方氨肽素片中氨茶碱与马来酸氯苯那敏的含量及含量均匀度。方法 色谱柱为YMC Hydrosphere C₁₈(4.6 mm×250 mm，5 μm)，流动相为乙腈-0.5%磷酸溶液(用三乙胺调pH值至2.2)(10∶90)，流速为1.0 mL·min^-1，柱温为30 ℃，检测波长为262 nm。结果 茶碱和马来酸氯苯那敏分别在0.06~0.58 mg·mL^-1和2.2~20.0 μg·mL^-1内线性关系良好，回收率分别为100.4%和101.2%，RSD分别为0.74%和1.40%(n=9)。结论 方法快速准确，重复性好，结果可靠，可同时测定氨茶碱及马来酸氯苯那敏，为产品质量标准提高提供基础。

Abstract:

OBJECTIVE To establish a method for the content and content uniformity of aminophylline and chlorphenamine maleate in compound amino-polypeptide tablets by HPLC. METHODS The YMC Hydrosphere C₁₈ column (4.6 mm×250 mm, 5 μm) was used with the mobile phase of acetonitrile-0.5% H₃PO₄(adjust pH to 2.2 by triehtylamine)(10∶90). The flow rate was 1.0 mL·min^-1. The column temperature was 30 ℃. The wavelength was 262 nm. RESULTS The calibration curves of aminophylline and chlorphenamine maleate were 0.06-0.58 mg·mL^-1 and 2.2-20.0 μg·mL^-1 respectively. Their recoveries were 100.4% and 101.2%, with RSDs of 0.74% and 1.40% (n=9), respectively. CONCLUSION The method is rapid, accurate and high efficiency to determinate aminophylline and chlorphenamine maleate simultaneously, so as to provide the basis for product quality standards.