HPLC法测定复方氨酚烷胺片中马来酸氯苯那敏的含量及含量均匀度

Determination of Content and Content Uniformity of Dosage Units of Chlorphenamine Maleate in Compound Paracetamol and Amantadine Hydrochloride Tablets by HPLC

目的：建立复方氨酚烷胺片中马来酸氟苯那敏的含量及含量均匀度的HPLC测定法。方法：色谱柱：Scienhome色谱柱（Kromasil C18，4．6mm×250mm，5μm）；流动相：乙腈旬-3％十二烷基硫酸钠溶液-磷酸（60：40：0．02）（用三乙胺调节pH值至3．3±0．1）；检测波长：210nm。结果：马来酸氟苯那敏在16．01-64．04mg·L^-1范围内线性关系良好，回归方程：A=2283 5ρ＋2926．6，r=0．9998。平均加样回收率为99．6％，RSD为0．41％。结论：本方法简便、灵敏、准确。

Objective ：To establish the method for determining the content and Content uniformity of dosage units of chlorphenamine maleate in Compound Paracetamol and Amantadine Hydrechloride Tablets by HPLC. Methods：The analytical column was Scienhome column（ Kromasil C18 ,4. 6 mm ×250 mm, 5 μm）. The mobile phase consisted of acetonitrile-0. 3% lanryl sodium sulfate-phosphate acid（60： 40： 0. 02）, detective wavelength was 210 nm;Resuits：Under this condition,there was a good linear relationship in the concentration range of 16. 01 - 64. 04 mg · L^-1 ,The regression equation was A = 2 283 5p ＋ 2 926. 6, r = 0. 999 8. Conclusion： This method is simple, sensitive and accurate.