头孢泊肟酯片溶出度测定方法

Study on the dissolution test of cefpodoxime proxetil tablets

目的制定头孢泊肟酯片新的溶出度测定方法，以解决日本橙皮书与中国药典方法在测定头孢泊肟酯片时溶出波动大的问题。方法参照美国药典、日本医瘵用医藁品品耍情鞭集（日本橙皮书）、中国药典，通过3种方法的对比，采用以甘氨酸．氯化钠缓冲液900mL为溶出介质，转速75r／min，紫外分光光度法测定头孢泊肟酯片的溶出量，测定波长260nm。结果线性浓度范围1．340-16．076μg／mL，r=0．9999，3批样品溶出量均大于85％。结论该方法准确、重复性好。

Objective A method for determination of cefpodoxime proxetil tablets was developed to resolve the unstability when determining by Japan Orange Book and Chinese Pharmacopoeia. Methods According to the United States Pharmacopoeia, Japan Orange Book and Chinese Pharmacopoeia, glycine-sodium chloride buffer was used as dissolution medium with the paddle rotated at 75r/min. The content of cefpodoxime proxetil tablets was determined by UV spectrophotometry with wavelength at 260nm. Results The range of linearity was 1.340-16.076μg/ mL, r=0.9999. Three batches dissolution content are higher than 85%. Conclusion The method is accurate and reproducible.