加米霉素含量测定方法的建立

Establishment of the Determination Method of Gamithromycin

[目的]建立用HPLC测定加米霉素含量的方法。[方法]采用高效液相色谱法,色谱柱为XBridge C_(18)柱(250 mm×4.6 mm,5μm),流动相为磷酸盐缓冲液(取0.05 mol/L磷酸氢二钾溶液,用稀磷酸调节pH至8.0)-乙腈(30∶70),流速为1.0 mL/min,柱温为30℃;检测波长为205 nm。[结果]加米霉素在0.498 4～1.993 6 mg/mL(r=0.999 9)峰面积与浓度呈良好的线性关系,平均加样回收率为99.2%,RSD=0.6%。[结论]该方法重复性良好,能准确测定加米霉素的含量。

[Objective]To establish an HPLC method for the determination of Gamithromycin.[Method]The separation was performed on a XBridge C 18 column(250 mm×4.6 mm,5μm),the mobile phase was composed of acetonitrile-phosphate buffer(0.05 mol/L dipotassium hydrogen phosphate solution,adjusted pH to 8 with phosphoric acid)(70∶30),the flow rate was 1.0 mL/min,column temperature was 30℃,detection wavelength was 205 nm.[Result]The calibration curve was linear at a range of 0.498 4-1.993 6 mg/mL for Gamithromycin(r=0.999 9),the average recovery was 99.2%and RSD was 0.6%.[Conclusion]The method was accurate with a good reproducibility and can be used as a quantitative analysis of Gamithromycin.