盐酸左西替利嗪片溶出度测定条件的研究
紫外分光光度法,正交试验
赵辉 吴燕 刘丽平 张福成[摘要] 目的:摸索盐酸左西替利嗪片体外溶出度测定条件。方法:依据《中国药典》2010年版和有关的参考文献,采用正交试验,考察溶出介质(0.1 mol/L盐酸溶液、pH 6.8的磷酸盐缓冲液及水)、转速(50、75、100 r/min)、取样时间(5、15、30 min)三个因素对盐酸左西替利嗪片体外溶出度测定的影响,采用紫外分光光度法,在230 nm波长下测定吸光度并计算溶出度。结果:盐酸左西替利嗪检测浓度为2~10 μg/ml(r=0.999 8),平均回收率为99.98%,RSD=0.28%;选择桨法,以水为溶出介质,转速为75 r/min,取样时间点为30 min是盐酸左西替利嗪片溶出度测定条件。结论:本法简便、可靠、准确,适合盐酸左西替利嗪片溶出度的测定。
[关键词] 盐酸左西替利嗪片;溶出度;正交试验;紫外分光光度法
[中图分类号] R917 [文献标识码]A[文章编号]1673-7210(2011)11(c)-034-03
Conditions test of Levocetirizine Dihydrochloride Tablets dissolution
ZHAO Hui, WU Yan, LIU Liping, ZHANG Fucheng
Department of Pharmacy, General Hospital of Air Force, Beijing 100142, China
[Abstract] Objective: To explore the conditions test of Levocetirizine Dihydrochloride Tablets dissolution in vitro. Methods: According to the methods of Chinese Pharmacopoeia (2010 edition) and other references, the influence to the dissolution conditions of Levocetirizine Dihydrochloride Tablets, such as dissolution mediums (0.1 mol/L hydrochloric acid solution, pH 6.8 phosphate buffer solution, water as medium), rotation speeds (50, 75, 100 r/min), and sampling time (5, 15, 30 min) were investigated by orthogonal experiment. The absorbance and release rate of solution were determined by UV spectrophotometry at 230 nm. Results: The assay displayed a good linearity over the concentration range of 2-10 μg/ml (r=0.999 8) with an average recovery was 99.98% (RSD=0.28%). Paddle method was adopted by using water as the solvent, and the rotation speed at 75 r/min with sampling time was 30 min. Conclusion: The method is simple, reliable and accurate, and it can be applied to determine dissolution of Levocetirizine Dihydrochloride Tablets. ......
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