摘要
目的:建立唑来膦酸的HPLC含量测定及有关物质检查方法。方法:采用ShimPackCLC-ODS不锈钢柱(150×4.6mm,5μm),以0.08%冰醋酸溶液(用三乙胺调pH至3.5)-0.1%四丁基氢氧化铵溶液(10:1)为流动相,流速1.0ml/min,检测波长211nm。进样量为20μL。结果:唑来膦酸进样量在1.5～15.5μg范围内具有良好的线性关系(r=0.9999,n=5),检测限为0.015μg/mL。结论:本方法分离效果好,准确、可靠、精密。
Objective： To establish a method for the determination of content and related substances of zoledronic acid by HPLC. Methods： A ShimPack CLC-ODS （150×4.6 mm, 5 μm） column was used as anylytical column with a mobile phase consisted of 0.08% acetic acid （adjust to pH 3.5 with triethylamine） -0.1% tetrabutylammonium hydroxiede （10：1）, the flow rate was 1.0 ml/min, the detection wavelength was 211 nm. Result： The linear range of zoledronic acid was 1.5-15.5 μg （r=0.999 9, n=5）, the lowest linit was 0.015 μg/ml. Conclusion： This method is accurate,sensitive, and precise.
出处
《中国当代医药》
2011年第36期46-47,共2页
China Modern Medicine
