对氯苯氧异丁酸甲氧基苯丙烯酸酯胶囊的溶出度测定

Determination of the Dissolution of(E)-4-[2-(4-chlorophenoxy)-2-methylpropanoyloxy]-3-methoxyphenyl Acrylic Acid Capsules

目的：建立对氯苯氧异丁酸甲氧基苯丙烯酸酯（AZ）胶囊溶出度的测定方法。方法：采用桨法，以0．8％的十二烷基硫酸钠溶液为溶出介质，转速为75r／min，45min时取样。以紫外分光光度法测定AZ胶囊的含量，检测波长为275nm。结果：AZ检测质量浓度线性范围为10．13~30．40μg／ml（r=0．9998）；平均回收率为100．3％（RSD=0．47％，n=3）；3批样品溶出45min时累积溶出度分别为（99．4±0．22）％、（99，0±O．26）％、（98。4±0．18）％，RSD分别为0．21％、0．25％、0．23％（n=6）。结论：所建立的方法操作简便、结果准确，可用于AZ胶囊的溶出度考察。

OBJECTIVE： To establish a method for determining the dissolution of （E）-4-[2-（4-chlorophenoxy）-2-methylpro- panoyloxy]-3-methoxyphenyl acrylic acid （AZ） capsules. METHODS： Paddle method was adopted using 0.8 % sodium dodecyl sul- fate solution as dissolution medium with a rotation speed of 75 r/rain. The samples were collected at 45 min. The contents of AZ capsules were determined by UV spectrophotometry at detection wavelength of 275 nm. RESULTS： The linear range of AZ was 10.13-30.40 μg/ml （r=0.999 8） with an average recovery rate of 100.3% （RSD=0.47%, n=3）. Accumulative dissolution rates of 3 batches of samples within 45 mitt were （99.4 ± 0.22）%, （99.0 ± 0.26）% and （98.4 ± 0.18）%, and RSDs were 0.21%, 0.25% and 0.23% （n=6）, respectively. CONCLUSIONS： The method is easy to operate and the results of determination are accurate. It can be used for the dissolution test of AZ capsule.