吴静芳
WU Jingfang

• 1:广州市药品检验所

摘要(Abstract)：

目的建立了HPLC法测定氨咖黄敏片中马来酸氯苯那敏的含量及含量均匀度。方法采用TSKgel ODS-100V(250mm×4.6 mm,5μm)色谱柱,甲醇-0.05 mol/L磷酸二氢钾溶液(含三乙胺0.03%,用磷酸调p H至3.0)(50∶50)为流动相,检测波长为215 nm。结果马来酸氯苯那敏的线性范围为9.809~29.428μg/m L(r=0.999 7),平均回收率为100.3%(RSD=0.5%,n=9)。结论本法简单准确,可用于氨咖黄敏片中马来酸氯苯那敏的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 paracetamol,caffein,atificial cow-bezoar and chlorphenamine maleate tablets. METHODS The sample was separated on a TSK gel ODS- 100 V column( 250 mm × 4. 6 mm,5 μm) with the mobile phase consisted of methanol- 0. 05 mol /L potassium dihydrogen phosphate solution( containing 0. 03% triethylamine,and the p H value was adjusted to 3. 0 with phosphate)( 50∶ 50). The detection wavelength was set at 215 nm. RESULTS There was a good linear relationship for chlorphenamine maleate in the range of 9. 809- 29. 428 μg / m L( r = 0. 999 7). The average recovery was 100. 3%( RSD = 0. 5%,n = 9). CONCLUSION This method is simple and accurate for the determination of content and content uniformity of chlorphenamine maleate in paracetamol,caffein,atificial cow-bezoar and chlorphenamine maleate tablets.

关键词(KeyWords)： 高效液相色谱法;氨咖黄敏片;马来酸氯苯那敏;含量;含量均匀度
HPLC;chlorphenamine maleate tablets;chlorphenamine maleate;content;content uniformity

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基金项目(Foundation):

作者(Author): 吴静芳
WU Jingfang

参考文献(References)：

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