泰乐菌素高效液相色谱检测方法的建立

Establishment of HPLC Method for Determination of Tylosin

[目的]为了更加简便快速地检测出产品中泰乐菌素的含量,建立了泰乐菌素高效液相色谱检测方法。[方法]检测波长290 nm,流速0.6 mL/min,进样量20μL,色谱柱选用C 18,柱温30℃,流动相选用乙腈∶甲醇∶0.025 mol/L磷酸二氢铵=25∶30∶5。[结果]进样浓度在0.5~50.0μg/mL与峰面积呈良好的线性关系(R 2=0.9999);回收率较高,均在80%以上,变异系数在允许范围内(0~5%);仪器重现性试验中,对照品连续进样10次,峰面积RSD为1.55%。[结论]高效液相色谱法检测泰乐菌素及其制剂的含量准确可靠,稳定性、重复性好,精密度高,适用于兽药企业对泰乐菌素及其制剂质量自控。

[Objective]In order to detect the tylosin content in the product more simply and quickly,a tylosin high performance liquid chromatography method was established.[Method]The detection wavelength was 290 nm,and the flow rate was 0.6 mL/min,and the injection volume was 20μL,and the liquid chromatography was carred out by C 18,and the column temperature was 30℃.With the mobile phase was acetonitrile∶methanol∶0.025 mol/L ammonium dihydrogen phosphate=25∶30∶45.[Result]The injection concentration of 0.5-50.0μg/mL had a good linear relationship with the peak area(R 2=0.9999);the recovery rate was above 80%,and the coefficient of variation was within the allowable range(0-5%).In the instrument reproducibility test,ten successive injections of reference,the peak area RSD was 1.55%.[Conclusion]The detection of tylosin and its preparations by high performance liquid chromatography is accurate and reliable,with good stability,reproducibility and high precision.It is suitable for veterinary drug companies to control the quality of tylosin and its preparations.