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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,5μm),流动相为乙腈-0.5%磷酸溶液(用三乙胺调p H值至2.2)(10∶90),流速为1.0 m L·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·m L-1和2.2~20.0μg·m L-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。
OBJECTIVE To establish an HPLC method for the determination of aminophylline and chlorphenamine maleate in Compound Aminopeptin tablets. Methods The column was YMC Hydrosphere C18 (4.6 mm × 250 mm, 5 μm). The mobile phase consisted of acetonitrile-0.5% phosphoric acid solution (pH value adjusted to 2.2 with triethylamine) (10:90) at a flow rate of 1.0 mL · min-1, the column temperature was 30 ℃, the detection wavelength was 262 nm. Results The theophylline and chlorphenamine maleate showed good linearity in the range of 0.06-0.58 mg · m L-1 and 2.2-20.0 μg · mL-1, respectively, and the recoveries were 100.4% and 101.2%, respectively. The RSDs were 0.74% and 1.40% (n = 9). Conclusion The method is rapid, accurate, reproducible and reliable. Simultaneous determination of aminophylline and chlorpheniramine maleate can provide the basis for the improvement of product quality standards.