【摘要】 采用D iamonsil C18色谱柱,流动相为0.1 mol/L醋酸铵溶液(pH 5.5)-甲醇-乙腈(40∶55∶5,V/V);流速0.8 mL/m in,柱温60℃,检测波长231 nm。在该色谱条件下,吉他霉素的9个主组分及5个小组分均能被完全分离并由LC-MS在色谱图中定位;诸组分在10~100μg范围呈良好线性(r>0.999);最低定量限小于1μg;方法的重复性、粗放性均满足质控分析的需要;已被中国药典2005版收载用于吉他霉素的组分控制。更多还原

【Abstract】 A high performance liquid chromatographic（HPLC） method for determination of active ingredients of kitasamyin has been developed.The chromatographic conditions included a Diamonsil C₁₈ column（250 mm×4.6mm,5 μm particle size） and the mobile phase consisting of 0.1 mol/L ammonium acetate-methanol-（acetonitrile）（40∶55∶5,V/V）,at a flow rate of 0.8 mL/min,the wavelength of ultraviolet detector was set at 231 nm and the column temperature was kept 60℃.Nine of the major active ingredients of kitasamyin and five of the minor ones can be separated completely and recognized by liquid chromatography-mass spectrometry at the chromatogram.The linear range was of 10¹00 μg（r>0.999） and the limit of detection was less than（1 μg）.The repeatbility and ruggedness/robustness of the method are satisfied for quality control.In（Chinese） pharmacopoeia 2005 version,the HPLC method has been used to control active ingredients of kitasamyin raw material.更多还原