HPLC法测定银菊感冒胶囊中马来酸氯苯那敏的含量及含量均匀度

Determination of Content and Content Uniformity of Chlorpheniramine maleate in Yunju Ganmao Capsules by HPLC

目的:建立测定银菊感冒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法。方法:采用Amethyst C18色谱柱(4.6 mm×200 mm,5μm),磷酸盐缓冲液(取磷酸二氢铵11.5 g,加水适量使溶解,加磷酸1 mL,用水稀释至1000 mL)-乙腈(80∶20)为流动相,流速1.0 mL?min^-1,检测波长262 nm,柱温为30℃。结果:马来酸氯苯那敏质量浓度在0.893~44.65μg/mL范围内线性关系良好,r=0.9999(n=6),平均回收率为100.95%,RSD=0.67%(n=5)。结论:该方法快捷,操作简便,结果可靠,可用于银菊感冒胶囊中马来酸氯苯那敏的含量测定和含量均匀度检测。

Objective To establish an HPLC method for the determination of Content and Content Uniformity of chlorpheniramine maleate in Yunju Ganmao capsules.Methods The HPLC assay carried out on an Amethyst C18 chromatographic column(4.6 mm×200 mm,5μm),Phosphate buffer(11.5g ammonium dihydrogen phosphate,dissolved by adding appropriate amount of water,1ml phosphate,diluted to 1000mL with water)-acetonitrile(80:20)was the mobile phase.The detection wavelength was set at 262 nm,flow rate at 1.0 mL?min^-1 and column temperature at 30℃.Results Chlorphenamine maleate had a good linear relationship within 0.893~44.65μg/mL,r=0.9999(n=6),average recovery rate was 100.95%,RSD=0.67%(n=5).Conclusion The method is quick,simple and reliable,and can be used for the determination of chlorpheniramine maleate in Yunju Ganmao Capsules and the determination of content uniformity.