摘要
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.
出处
《中国药房》
CAS
CSCD
2014年第13期1207-1209,共3页
China Pharmacy
基金
江西重大战略产品科技专项资助研究课题(No.2008212)
关键词
对氯苯氧异丁酸甲氧基苯丙烯酸酯胶囊
溶出度测定
桨法
紫外分光光度法
(E)-4-[2-(4-chlorophenoxy)-2-methylpropanoyloxy]-3-methoxyphenyl acrylic acid capsules
Dissolution determina- tion
Paddle method
UV spectrophotometry