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HPLC法测定雷奈酸锶干混悬剂的含量
Determination of Strontium Ranelate for Suspension by HPLC
【摘要】 目的建立雷奈酸锶干混悬剂含量的高效液相色谱测定方法 .方法采用Angilent Zorbax C18(4.6mm×250mm,5μm)色谱柱,流动相为0.2%(v/v)磷酸溶液-甲醇(85∶15)用三乙胺调节pH5.0,流速为1.0mL·min-1,检测波长234nm.结果在该色谱条件下,雷奈酸锶在4.96~248.00μg·mL-1浓度范围内线性关系良好,重复性试验RSD为0.71%,平均回收率为99.15%(RSD=0.57%).结论本法灵敏、准确、重复性好,可用于雷奈酸锶干混悬剂的质量控制.
【Abstract】 OBJECTIVE To establish a method for determination of Strontium Ranelate for Suspension by HPLC.METHODS The system used Angilent Zorbax C18 column(4.6mm×250mm,5μm),and 0.2%(V/V) phosphate acid-methanol(85∶15),adjusted to pH5.0 with triethylamine as mobile phase with flow rate of 1.0mL·min-1,with detection wavelength at 234nm.RESULTS The liner range of strontium ranelate was 4.96~248.00g·mL-1.The RSD of repeatability test was 0.71%.The average recovery of strontium ranelate was 99.15%(RSD=0.57%).CONCLUSION The method was sensitive,accurate and can be used to control the quality of Strontium Ranelate for Suspension.
- 【文献出处】 齐鲁药事 ,Qilu Pharmaceutical Affairs , 编辑部邮箱 ,2010年12期
- 【分类号】R927.2
- 【被引频次】2
- 【下载频次】90