格列齐特片(Ⅱ)两种含量测定方法比较  

Comparison between the Two Determination Methods of Gliclazide in Gliclazide Tablets(Ⅱ)

作　　者：杜宁[1] 钱文[1] 周艳丽[2] 

机构地区：[1]江苏省药品检验所,南京210008 [2]江苏省人民医院心内科,南京210029

出　　处：《中国药品标准》2007年第1期72-74,共3页Drug Standards of China

摘　　要：目的：建立格列齐特片含量的HPLC测定方法，并与2005年版《中国药典》，电位滴定法比较。方法：以C18柱，甲醇-0.2%冰醋酸（55：45）为流动相，流速为1.0ml／min，柱温30℃。检测波长为229nm。结果：在浓度为4．02～12．06mg／L范围内，本法线形关系良好，相关系数r=0.9996，回收率为99．6％（n=5），重复性试验RSD为0．9％（n=7）。结论：与药典方法比较，更简单，准确，快捷，污染少。Objective：To develop a new HPLC method of determining Gliclazide in Gliclazide Tablets （ Ⅱ ） and compare with a Potentio-metric one in Chp 2005. Methods：The determination was carried out on a C14 column. The mobile phase was methanol-0. 2% glacial acetic acid solution（55 ： 45） with flow rate of 1.0ml/min and the column temperature was 30℃. The detection wavelength was 229nm. Results：There was a good linearity over the range of 4.02～12. 06mg/L with a coefficient of correlation（r）0. 9996 （n= 6）. The mean recovery was 99.60% with RSD 0. 90% （n= 5）. The RSD for repetition was 0.9 % （n= 7）, Conclusion ：In comparison with Potentio-metric method ,it is simple, rapid,accurate and less polluted.

关 键 词：格列齐特片 含量测定 电位滴定法 HPLC 

分 类 号：R921.2[医药卫生—药学]