RP-HPLC法测定雷尼酸锶中有关物质和含量  

Determination of strontium ranelate and its related substances by RP-HPLC

作　　者：谢银彩[1,2] 朱雄[3] 沈卫阳[1,2] 

机构地区：[1]中国药科大学分析化学教研室,南京210009 [2]药物质量与安全预警教育部重点实验室,南京210009 [3]中国药科大学医药化工研究所,南京210009

出　　处：《海峡药学》2011年第12期84-86,共3页Strait Pharmaceutical Journal

摘　　要：建立雷尼酸锶中有关物质检查与含量测定的RP-HPLC法,以Diamonsil C18柱(250mm×4.6mm,5μm);0.2%冰醋酸溶液(用三乙胺调节pH值至5.5)-甲醇(95∶5)为流动相,检测波长为234nm。在选定的色谱条件下,雷尼酸锶与有关物质及中间体分离完全,雷尼酸锶在0.005～0.250mg.mL-1范围内,峰面积与浓度线性关系良好(r=1),检测限为15ng,定量限为50ng。RP-HPLC methods for the determination of strontium ranelate and its related substances were developed to control the quality of strontium ranelate.Chromatography was carried out on a Diamonsil C18 column（250mm×4.6mm,5μm）,using a mobile phase of 0.2% acetic acid buffer（pH=5.5,adjusted by triethylamine）：methanol（95∶5） with the ultraviolet detection wavelength at 234nm.Under the established chromatographic conditions,the related substances,intermediate and strontium ranelate can be separated completely.The established methods have been validated,and stability tests under various conditions have been performed.The standard curve is linear within the range of 0.005～0.250mg·mL-1 with the correlation coefficient of 1.The limits of detection and quantification were 15.0ng and 50.0ng,respectively.

关 键 词：HPLC 雷尼酸锶 有关物质 含量测定 

分 类 号：R917[医药卫生—药物分析学]