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目的建立格列齐特缓释片有关物质和含量的测定方法。方法采用高效液相色谱法,色谱柱:辛烷基硅烷键合硅胶,4.6×250mm(COSMOSIL);流动相:水-乙腈-三乙胺-三氟乙酸(60:40:0.1:0.1);检测波长:235nm。结果格列齐特的线性方程:A=30256C+5526.6,r=0.999(0.05008～0.40064g/ml)。结论本方法灵敏、准确,能够有效控制制剂中的格列齐特杂质Ⅰ,可作为格列齐特缓释片有关物质和含量测定方法。
Objective To establish a method for the determination of substances and contents of gliclazide sustained-release tablets. Methods High performance liquid chromatography (HPLC) was used. The column was octane - silane bonded silica gel (4.6 × 250 mm, COSMOSIL). The mobile phase was water - acetonitrile - triethylamine - trifluoroacetic acid Detection wavelength: 235nm. Results Gliclazide’s linear equation: A = 30256C + 5526.6, r = 0.999 (0.05008-0.40064 g / ml). Conclusion The method is sensitive and accurate and can effectively control the Gliclazide impurity Ⅰ in the preparation, which can be used as the related substance and content determination method of Gliclazide sustained - release tablets.