高效液相色谱法测定茶新那敏片中盐酸溴己新含量

Content Determination of Bromhexine Hydrochloride In Aminophylline Bromhexine and Chlorphenamine Tablets by HPLC

目的建立测定茶新那敏片中盐酸溴己新含量的高效液相色谱(HPLC)法。方法色谱柱为Phenomenex C18柱(250mm×4.6mm,5μm),以用三乙胺调节pH至3.5的甲醇-0.2%磷酸溶液(65∶35)为流动相,柱温为室温,流速为1.0mL/min,检测波长248nm。结果盐酸溴己新进样量在0.604～2.416μg范围内与峰面积线性关系良好,r=0.9999(n=5),平均回收率为99.45%,RSD为0.82%(n=6)。结论HPLC法简便、准确,可作为茶新那敏片质量控制方法。

Objective To establish a HPLC method for the content determination of bromhexine hydroehloride in Aminophylline Bromhexine and Chlorphenamine Tablets. Methods The determination was performed on Phenomenex C18 column（250 mm ×4.6 mm,5 μm）with the mobile phase consisted of methanol-0. 2% phosphoric acid solution （65：35, pH was adjusted to 3.5 with triethylamine） at ambient temperature. The flow rate was 1.0 mL/min. The detection wavelength was 248 nm. Results The method showed a good linear relationship for bromhexine hydroehloride within the range of 0. 604 -2. 416 μg （ r =0. 9999, n =5）. The mean recovery rate was 99.45% with RSD was 0. 82% （ n =6）. Conclusion The method is simple, accurate. It can be used for quality control of Aminophylline Bromhexine and Chlorphenamine Tablets.