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.
出处
《海峡药学》
2011年第12期84-86,共3页
Strait Pharmaceutical Journal
