摘要
目的建立HPLC法测定甲磺酸伊马替尼原料药的含量。方法采用ZorbaxSB—C18色谱柱（250mm×4．6mm，5μm），柱温30℃，流动相为乙腈-水-三乙胺（22：77：1，首先配制三乙胺水溶液，用85％磷酸调pH3．5），流速1．1mL·min-1，检测波长268nm，进样体积20μL。结果甲磺酸伊马替尼原料药5～500μg·mL-1与峰面积呈良好的线性关系（r=0．9999，n=10），检测限1ng·mL-1，平均回收率及RSD分别为99．82％、0．2％（n=9）。结论所用方法灵敏准确，可为甲磺酸伊马替尼原料药的质量控制提供试验依据。
OBJECTIVE To develop an HPLC method for the content determination in the raw material of Imatinib mesylate. METHODS An Zorbax SB -C18 column（250 mmx 4.6 mm ,5 μm）was used with a mobile phase of aeetonitrile -water- triethyl- amine（22 ： 77 ： 1 ）, and the aqueous solution of triethylamine was adjusted to pH3.5. The detection wavelength was set at 268 nm, the column temperature was 30 ℃ ,and the flow rate was 1.1 mL.min-1. The injection volume was 20 μL. RESULTS The linear range of lmatinib mesylate was 5 - 500 μg mL- 1 （r= 0. 9999, n = 10）. The detection limit for Imatinih mesylate was 1 ng. mL - 1. The average recovery of Imatinib mesylate was 99.82% （ RSD = 0.2% , n = 9 ）. CONCLUSION The method is simple, reliable, accurate and very suitable, which can be used for the content determination of Imatinib mesylate.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2013年第6期626-628,共3页
West China Journal of Pharmaceutical Sciences
