HPLC测定扎西他宾薄膜衣片的溶出度  

Dissolution determination of Zalcitabine from film-coated tablets by HPLC

作　　者：张颖[1] 王宇驰 唐克慧[1] 张春然[1] 

机构地区：[1]四川抗菌素工业研究所,四川成都610051

出　　处：《华西药学杂志》2007年第4期433-435,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的建立定量测定扎西他宾薄膜衣片溶出度的方法。方法采用HPLC法,AlphaBond-C18柱(150 mm×3.9 mm,10μm),流动相为磷酸缓冲液-甲醇-乙腈(96:4:3),检测波长270 nm。结果0.005～20.000μg.ml-1的线性方程为:A=4.455×105C+1.770×104(r=0.9999);平均回收率为99.28%,RSD=0.83%(n=9);5批样品溶出迅速,批间差异小。结论所建方法简单,专属性强,可测定扎西他宾薄膜衣片的溶出度。自制片剂和进口参比制剂溶出度相似。OBJECTIVE To establish an HPLC method for the quantitative determination of Zalcitabine from film - coated tablets. METHODS The HPLC method was proceeded on AlphaBond - Cis （ 150 mm × 3.9 mm, 10μm） column with the degassed mixture of phosphate buffer and methanol and acetonitrile （96 ： 4 ： 3） as mobile phase, and the detection wavelength at 270 nm. The dissolution tests were performed according to China Pharmacopoeia 2005 dissolution test apparatus 2. RESULTS The linearity range was 0. 005 - 20. 000 μg· ml^-1 （ r = 0. 9999）. The average recovery was 99. 28% with the RSD of 0. 83% （ n = 9 ）. Precisions of the method in three dosage group were found to be 0. 39% ,0. 39% and 0. 37% （ n = 5 ）, respectively. Rapid dissolution of Zalcitabine from six batches was observed. CONCLUSION The simple HPLC method with good specificity may be used for the accurate dissolution determination of Zalcitabine film - coated tablets. The dissolution profile of tablets made by self resembles that of imported ones.

关 键 词：扎西他宾 高效液相色谱法 溶出曲线 

分 类 号：R917[医药卫生—药物分析学]