文档介绍：
马来酸罗格列***缓释片有关物质的测定
[摘要] 目的：建立RP-HPLC法测定马来酸罗格列***缓释片的有关物质。方法：采用ODS DiamonsilTM C18（250 mm× mm，5 μm）色谱柱，流动相为乙***- mol/L醋酸钠水溶液（冰醋酸调pH=）（57∶43）。检测波长为247 nm， ml/min。结果：罗格列***与各杂质及降解产物分离良好，在10~60 μg /ml浓度范围内线性关系良好（r= 9），%，%，最低检测限为10 ng，最低定量限为70 ng。结论：该方法简便、快速、准确、灵敏度高、重复性好，可用于马来酸罗格列***缓释片有关物质的测定。
[关键词] 马来酸罗格列***缓释片；有关物质；反相高效液相色谱法
[中图分类号]R917 [文献标识码]A [文章编号]1673-7210（2008）05（b）-029-03
Determination of related substances of self-made Rosiglitazone Maleate Sustained Released Tablets
PANG Xiao-hua,CHEN Chun-shui
(The fourth Manufacture Department, Guangzhou Baiyunshan Pharmaceutical General Factory, Guangzhou 510515,China)
[Abstract] Objective: To establish RP-HPLC method to determine the the related substances of Rosiglitazone Maleate Sustained Released :The column was C18(250 mm× mm,5 μm),the mobile phase was composed by acetonitrile- mol/L sodium acetate (glacial acetic acid adjusting pH to ) (57∶43) , the detective wavelength was set at 247 nm, and the flow rate was ml/min. Results: The separation of rosiglitazone maleate,impurity and degradation product was linear range was 10~60 μg/ml(r= 9),the average recovery was %(RSD=%),the lowest detectable limit and the lowest quantitation limit were 10 ng and 70 ng :The method is con