HPLC测定克拉霉素及其制剂的含量

Determination of Clarithromycin by HPLC

目的 采用HPLC法测定克拉霉素及其制剂的含量。方法 C1 8或C8色谱柱 (4 .6mm× 2 5 0mm ,5 μm) ,流动相分别为磷酸二氢钾溶液 (0 .0 6 7mol·L- 1 ) -甲醇 (4 0 0∶6 0 0 ) (pH 4 .0 )和磷酸二氢钾溶液 (0 .0 6 7mol·L- 1 ) -乙腈 (5 5∶4 5 ) ,检测波长 2 10nm ,均采用外标法。结果 3种方法线性范围均为 0 .0 2 5～ 2 .0mg·ml- 1 (r=0 .9999) ,平均回收率为 10 0 .2 % ,RSD =0 .4 8% (n =6 )。结论 3种方法的分离效果均较好 ,没有明显差异 ,其中方法b较为适宜。

OBJECTIVE To establish an HPLC method to determine the Clarithromycin and its concentration in the preparations.METHODS HPLC analysis was carried out by C 18 or C 8 column.The mobile phases were monobasic potassium phosphate(0.067 mol·L -1 )-methanol(400∶600) and monobasic potassium phosphate(0.067 mol·L -1 )-acetonitrile(55∶45).The detective wavelength was 210 nm.The concentration of Clarithromycin was quantified by external standard method.RESULTS All the linear range was 0.025-2.0 mg·ml -1 .The total average recovery was 100.2% with RSD of 0.48%( n =6).CONCLUSION Three methods are sensitive and rapid,but the method b is more convenient.