HPLC-ELSD法测定异帕米星含量  

Determination of Isepamicin by HPLC-ELSD method

作　　者：王明娟[1] 成双红[1] 张斗胜[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国抗生素杂志》2003年第1期20-22,共3页Chinese Journal of Antibiotics

摘　　要：目的　探讨利用HPLC 蒸发光散射检测器 (ELSD)测定异帕米星含量的方法。方法　色谱条件为 :ZorbaxSB C18色谱柱 (15 0mm× 4 6mm ,5 μm ) ,流动相 :0 5 %五氟丙酸水溶液—甲醇 (4 2∶2 2 ,V/V) ,流速 :0 64ml/min ;漂移管温度 110℃ ,载气流速 2 65L/min。利用阿米卡星为对照绘制随行标准曲线 ,根据测定的异帕米星标准品的峰面积值确定含量 ;并与经典的微生物检定法对测定结果的准确性进行验证。结果　该方法的重复性、灵敏度均较理想 ;HPLC 蒸发光散射检测器的测定结果 (69 7% )与微生物检定法的测定结果(70 7% )非常接近。结论　在没有异帕米星对照品的情况下 ,以结构相似含量已知的阿米卡星为对照 。Objective To approach an assay method of determination of isepamicin by HPLC ELSD, with a similar chemical structure substance amikacin as the reference. Methods The conditions were as follows: an ELSD as the detector; Zorbax SB C 18 (150mm×4.6mm, 5μm) column as analytical column; 0.5% pentafluoropropionic acid∶methanol (42∶22) as mobile phase; the content of isepamicin according to that of reference substance was determined. The microbiological assay was applied to verify the accuracy of the method. Results The result obtained with HPLC ELSD was concordant to that of the microbiological assay. Conclusion It′s feasible to determine isepamicin by HPLC ELSD, using a different substance with similar chemical structure as reference substance.

关 键 词：高效液相色谱法 蒸发光散射检测器 异帕米星 含量 测定 

分 类 号：R927.2[医药卫生—药学]