摘要
目的:对格列齐特缓释片进行质量标准研究。方法:释放度测定采用pH8.6的磷酸盐缓冲液1000ml为释放介质,转篮法,每分钟150转;高效液相色谱法测定含量,采用C8柱,流动相:乙腈-水-冰醋酸(45∶55∶0.1),流速为1.0ml·min-1,检测波长:228nm。结果:格列齐特缓释片体外释放曲线符合Higuchi方程:高效液相色谱法测定含量重现性好,准确可靠。结论:格列齐特缓释片的质量得到有效控制。
Objective：To study the quality specification of Gliclazide Sustained-release Tablet. Methods ：At the determination of its realease rate, basket method was used, 1000ml of phosphate buffer （pH8. 6）was used as release medium; the chromatographic conditions were as follows：C8 column and acetonitrile-water-glacial acetic acid （45 ： 55 ： 0. 1）as mobile phase with a follow rate of 1.0ml · min^-1 and a UV detector at 228nm. Results： The release profile of Gliclazide Sustained-release Tablet followed Higuchi kinetics ：an accurate,reproducible HPLC method was established. Conclusion：This standard was capable to effectively control the quality of Gliclazide Sustained-release Tablet.
出处
《中国药品标准》
CAS
2005年第4期56-58,共3页
Drug Standards of China
