RP-HPLC法测定吲哚美辛5-氟尿嘧啶甲酯原料药含量及有关物质  

Determination of indomethacin 5-fluorouracil-1-ylmethyl ester and its related substances by RP-HPLC

作　　者：汪广厚[1] 王晶[1] 齐伟[1] 陈扬[1] 孙立新[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2008年第7期563-566,共4页Journal of Shenyang Pharmaceutical University

摘　　要：目的用RP-HPLC法测定吲哚美辛5-氟尿嘧啶甲酯原料药含量和有关物质。方法色谱柱：DiamonsilTMC18（250 mm×4.6 mm,5μm）,流动相：甲醇-0.025 mol·L^-1醋酸铵（体积比为65∶35）（用冰醋酸调节pH至3.5）,流速：1 mL·min^-1,检测波长：260 nm,柱温：40℃。结果在选定的色谱条件下,有关物质与主药分离良好,最低检测限2.0μg·L^-1,吲哚美辛5-氟尿嘧啶甲酯的质量浓度在5.0～50.0 mg·L^-1内线性关系良好（r=0.999 9）,平均回收率99.7%,RSD=1.0%。结论该法适用于吲哚美辛5-氟尿嘧啶甲酯原料药含量和有关物质检查。Objective To establish an RP-HPLC method for the determination of contents of indomethacin 5- fluorouracil-1-ylmethyl ester and its related substances. Methods The Diamonsil^TM C18（250 mm × 4.6 mm, 5 μm） was used and mobile phase was consisted of methanol-0. 025 mol·L^-1 ammonium acetate （ V ： V = 65：35）, （using acetic acid to adjust pH to 3.5）. The detection wavelength was set at 260 nm, the flow rate was 1.0 mL·min^-1, the column temperature was 40 ℃. Results The linear calibration curves were obtained in the concentration range of 5.0 - 50.0 mg· L^- 1（ r = 0. 999 9）. The mean recovery was 99.7 % with RSD of 1.0 %. The detection limit was 2.0 μg·L^- 1. Conclusions This accurate and reliable RP-HPLC method is applicable for the quality control of indomethacin 5-fluorouracil-1-ylmethyl ester and its related substances.

关 键 词：反相高效液相色谱法 吲哚美辛5-氟尿嘧啶甲酯 含量测定 有关物质 

分 类 号：R917[医药卫生—药物分析学]