HPLC分离测定格列齐特片及其有关物质  

Determination of gliclazide and its related substances in gliclazide tablets by HPLC

作　　者：钱亚萍[1] 柳建义 程爱平[1] 张关顺[1] 

机构地区：[1]嘉兴市药品检验所,嘉兴314001 [2]嘉兴市医药集团公司

出　　处：《中国现代应用药学》2001年第3期234-236,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的 :建立新的 HPL C法分离测定格列齐特片及其有关物质。方法 :色谱条件为 :Shim- Pack VP- ODS(5 μm,15 0 mm×4.6 m m i.d.)色谱柱 ;甲醇 - 0 .0 2 m ol/ L 磷酸 (用三乙胺调节 p H至 3.5 ) (70∶ 30 )为流动相 ;检测波长为 2 2 9nm。结果 :在 5 0～ 30 0μg/ m l的浓度范围内线性关系良好 ,r=0 .9999(n=6 ) ;平均回收率为 10 0 .5 % ,RSD为 0 .17% (n=6 ) ;重复进样 RSD为0 .12 % (n=6 ) ;格列齐特及其有关物质得到基线分离。结论 :本法简便、快速、准确 。OBJECTIVE:To develop a new HPLC method for isolation and determination of gliclazide and its related substances.METHODS: The chromatographic precedure was carried out on Shim pack vp ODS(5 μm, 150 mm×4.6 mm i.d.), the mobile phase was methanol -0.02mol/L phosphoric acid previously adjusted to pH3.5 with triethylamine(70∶30) with flow rate of 1ml/min.The detection wave length was 229 nm. RESULTS: There was a good linearity over the range of 50～300 μg/ml with a coefficient of correlation (r) 0.9999 (n=6). The mean recovery was 100.5% with RSD 0.17% (n=6).The RSD for repetition was 0.12% (n=6).The peak of Gliclazide and its related substances were separated completely. CONCLUSION: The method was simple, rapid,accurate and can be used to control gliclazide and its preparations.

关 键 词：格列齐特 格列齐特片 HPLC 含量测定 

分 类 号：R927.2[医药卫生—药学] R977.15