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2~10μg/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。
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.
出处
《中国医药导报》
CAS
2011年第33期34-36,共3页
China Medical Herald
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
Levocetirizine Dihydrochloride Tablets
Dissolution
Orthogonal experiment
UV spectrophotometry
