HPLC法测定甲磺酸酚妥拉明泡腾片含量及有关物质

Determination of Content and Related Substances in Phentilamine Mesylate Effervescent Tablets by HPLC

目的：采用反相高效液相色谱法测定甲磺酸酚妥拉明泡腾片的含量及其有关物质。方法：采用C18柱，以醋酸溶液（取冰醋酸1ml，加水至1000ml，用三乙胺调节pH值至3．8）．甲醇（53：47）为流动相；流速为1．0ml·min^-1；检测波长为278nm。结果：杂质峰与主峰均能有效分离，甲磺酸酚妥拉明在12．008—48．032μg·ml^-1浓度范围内线性关系良好（r=0．9999），平均回收率为99．52％，RSD为0．73％（n=9）。结论：本法简便、准确，专属性好，为提高甲磺酸酚妥拉明泡腾片现行标准提供了参考依据。

Objective： To establish a method for the determination of the related substances and the content of phentilamine mesylate effervescent tablets by HPLC. Methods： A C18 column was used with acetic solution （ lml glacial acetic acid was diluted to 1 000 ml by water, and then adjusted pH to 3.8 with triethylamine） and methanol （53： 47） as the mobile phase, and the flow rate was 1.0 ml · min^-1 with the UV detection wavelength at 278 nm. Results： Phentilamine mesylate and its related substances could be completely separated by the method. The linear range Was 12. 008-48. 032 μg ·ml^-1 （r = 0. 999 9）. The average recovery was 99.52% （RSD = 0.73 %, n =9）. Conclusion： The method is simple, rapid, accurate and specific in the determination of phentilamine mesylate and its related substances, which provides reference for the improvement of current quality standard.