不同生产企业五氟利多片含量均匀度考察

Study on Content Uniformity for Penfluridol Tablets from Different Manufacturers

目的:考察不同企业生产的五氟利多片的含量均匀度。方法:采用HPLC法,Diamonsil^(TM)C_(18)(4.6 mm×250 mm,5μm)色谱柱,流动相为甲醇-0.2%三乙胺溶液(用磷酸调节p H值至2.5)(70∶30),检测波长219 nm。结果:不同企业生产的五氟利多片的含量均匀度检查结果差异较大。结论:五氟利多片标准中增加含量均匀度检查项,可以加强对生产企业的监督管理,保证药品质量。

Objective： To investigate the content uniformity of Penfluridol Tablets from different manufacturers. Methods ： HPLC method was performed on a DiamonsilTMC19 column（4. 6 mm ×250 mm, 5 μm）, the mobile phase was consisted of methanol -0. 2% triethylamine solution （adjusted pH to 5. 5 with phosphoric acid） （70： 30） and the detection wavelength was set at 219 nm. Results：There were significant differences in content uniformity of Penfluridol Tablets from different enterprises. Conclusion： Adding content uniformity item to the official standard of Penfluridol Tablets could reinforce the management of pharmaceutical enterprises and guarantee the quality of the drugs.