高效液相色谱法测定复方银翘氨敏胶囊中马来酸氯苯那敏含量及含量均匀度

Determination of Content and Content Uniformity of Chlorphenamine Maleate in Compound Yinqiao and Paracetamol and Chlorphenamine Maleate Capsules by HPLC

目的建立测定复方银翘氨敏胶囊中马来酸氯苯那敏含量及含量均匀度的高效液相色谱(HPLC)法。方法采用XTerra RP18色谱柱(250 mm×4. 6 mm,5μm),以甲醇为流动相A,0. 02 mol/L磷酸二氢钾溶液-三乙胺(100∶0. 1)为流动相B,梯度洗脱,流速为1. 0 m L/min,柱温为35℃,检测波长为262 nm。结果马来酸氯苯那敏质量浓度在4. 56～114. 06μg/m L范围内与峰面积线性关系良好,r=0. 999 9(n=6),平均回收率为101. 04%,RSD为1. 65%(n=6)。结论该方法可用于该制剂中马来酸氯苯那敏含量及含量均匀度的测定。

Objective To established an HPLC method for the determination of content and content uniformity of chlorphenamine maleate in Compound Yinqiao and Paracetamol and Chlorphenamine Maleate Capsules. Methods The chromatographic column was XTerra RP18 column（250 mm ×4.6mm,5 μm）,the mobile phase A was methanol,the mobile phase B was 0.02 mol/L potassium dihydrogen phos- phatetriethylamine（100：0. 1）,gradient elution,the flow rate was 1.0 mL/min,the column temperature was 35 ℃,and the detection wavelength was 262 nm. Results There was a good linear relationship for chlorphenamine maleate in the range of 4. 56- 114. 06 μg/mL, r = 0. 999 9（n = 6）. The average recovery rate was 101.04%, RSD was 1.65% （n = 6）. Conclusion The method can be used for the determination of content and content uniformity of chlorphenamine maleate in Compound Yinqiao and Paracetamol and Chlorphenamine Maleate Capsules.