高效液相色谱法测定辛伐他汀含量及其有关物质  

HPLC Determination of Simvastatin and Its Related Substances

作　　者：林缨[1] 谢剑炜[1] 

机构地区：[1]军事医学科学院毒物药物研究所,北京100850

出　　处：《药物分析杂志》2005年第5期523-525,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立辛伐他汀的含量及其有关物质的反相高效液相色谱测定方法。方法:采用 ZORBAX SB-C_(18)(4.6mm×250mm,5μm)色谱柱,以乙腈-0.025mol·L^(-1)磷酸二氢钠(65∶35)为流动相,流速为1.0mL·min^(-1),检测波长为238nm。结果:在所选定的液相色谱条件下,有关物质与主药分离良好,辛伐他汀在2-200μg·mL^(-1)范围内线性良好,检出灵敏度为5ng·mL^(-1),RSD<3%。结论:该方法操作简便,重复性好,专属性强,可用于辛伐他汀的含量测定及杂质检查。Objective:To establish an RP-HPLC method for determination of simvastatin and its related sub- stances.Methods:Chromatographic conditions were as follows:a ZORBAX SB-C_(18) column(4.6mm×250mm, 5μm),a mobile phase of CH_3CN-0.025 mol·L^(-1) NaH_2PO_4(65:35),a flow rate of 1.0 mL·min^(-1),and a de- tection wavelength of 238 nm.Results:Simvastatin and its related substances can be completely separated by the method with a liner range of 2-200 μg·mL^(-1).A detection limit of 5ng·mL^(-1)and a RSD of<3% were ob- tained.Conclusion:A reproducible and sensitive method is provided for determination of simvastatin and its related substances.

关 键 词：辛伐他汀 有关物质 高效液相色谱法 反相高效液相色谱 磷酸二氢钠 检出灵敏度 测定方法 检测波长 色谱条件 杂质检查 含量测定 色谱柱 流动相 重复性 专属性 

分 类 号：R972.6[医药卫生—药品] R927.2[医药卫生—药学]