克拉霉素中4种相关物的HPLC检测

建立了一种高效液相色谱法等度分析克拉霉素及其4种相关物J、M、N和K的检测方法，并对其进行了方法学验证.采用Purospher STAR LP RP-18e型色谱柱，用0.067 mol/L KH₂PO₄溶液（pH4.0）/乙腈=60/40作为流动相，流速为1.2 mL/min，柱温为35℃，在205 nm进行检测，对克拉霉素及其4种相关物进行等度洗脱，获得了较好的分离度，均大于1.2.该方法在各相关物20~240μg/mL的浓度范围内线性良好（R>0.999）.平均回收率为87.80%~121.17%.本方法简便、高效，能够同时检测克拉霉素中的J、M、N和K几种相关物. 

Detection of 4 Relative Substances in Clarithromycin by HPLC

An effective method was established and verified for the detection of clarithromycin and its relative substances J,M,N and K by HPLC.Clarithromycin relative substances sample was separated by isocratic elution with a Purospher STAR LP RP-18e C18 column and with the mobile phase 0.067 mol/L KH2PO4 solution (pH 4.0)/acetonitrile =60/40,the flow rate of 1.2 mL/min,the column temperature 35 ℃ and detection wavelength 205 nm,and the separation degrees were greater than 1.2.Analysis results show that,the method can provide good linearity (R＞0.999) for all relative substances at the concentration range of 20～240 μg/mL,the average recovery rates keep at 87.80％～121.17％,its operation is simple and efficient,and can be able to simultaneously detect J,M,N and K in clarithromycin.