扎托洛芬片溶出度测定

Determination of the Dissolution of Zaltoprofen Tablets

目的:建立测定扎托洛芬片溶出度的方法。方法:含量测定方法采用紫外分光光度法,检测波长为330nm;溶出度测定方法采用桨法,以pH6.8的磷酸盐缓冲液为溶出介质,转速为100r·min-1,取样时间为30min。结果:扎托洛芬检测浓度的线性范围为2.5～30μg·mL-1(r=0.9999),平均回收率为100.36%,RSD=0.54%;3批样品30min时溶出度均在80%以上。结论:本方法简便、准确,结果可靠,可用于扎托洛芬片的溶出度测定。

OBJECTIVE： To establish a method for determining the dissolution of Zaltoprofen tablets. METHODS： The content determination was conducted by UV spectrophotometry with detection wavelength of 330 nm. The paddle method was applied to calculate dissolution with phosphoric acid buffer solution （pH 6.8） as solvent and rotation speed of 100 r·min^-1. After 30 min the sample was collected. RESULTS： The method showed a good linear relationship in the range of 2.5-30 μg·mL^-1（r= 0.999 9）. The average recovery was 100.36% （RSD=0.54%）. The dissolutions of 3 batches of samples were all above 80%. CONCLUSION： The method is simple, accurate, and reliable for the determination of the dissolution of Zaltoprofen tablets.