西他沙星片溶出度测定

目的:建立测定西他沙星片溶出度的方法。方法:按照2005年版《中国药典》(二部)桨法,以0.1mol.L-1盐酸为溶出介质,转速为75r.min-1,于30min取样,在295nm波长处采用紫外分光光度法测定其吸收度,并计算溶出度。结果:西他沙星检测浓度的线性范围为2～20μg.mL-1(r=0.999 6);平均回收率为99.95%,RSD=0.40%;3批样品30min溶出度均在90%以上。结论:本方法简便、准确、可靠,可用于该制剂的溶出度测定。

Determination of the Dissolution of Sitafloxacin Tablets

OBJECTIVE： To establish a method for the determination of the dissolution of sitafloxacin tablets. METHODS： The dissolution sitafloxacin tablets was determined by peddle method in accordance with Chinese Pharmacopeia （2005 edition） using 0.1 mol·L^-1 HCl as the medium with the rotation speed set at 75 r·min^-1 Sampling was carried at 30 min with its absorbability determined by UV spectrophotometry under a wavelength of 295 nm and its dissolution rate calculated. RESULTS： The linear range of sitafloxacin was 2～20/μg·mL^-1（r = 0.999 6） with an average recovery rate of 99.95% （RSD = 0.40% ） . The dissolution rates of 3 batches of samples were all above 90%. CONCLUSION： The method is simple, accurate with reliable results, and it is applicable for the determination the dissolution rate of sitafloxacin tablets.