超高效液相色谱法测定原料药中泰地罗新的含量

Determination of Tildipirosin in Drug Substance by Ultra High Performance Liquid Chromatography

关键词:  超高效液相色谱法  原料药  泰地罗新及其异构体  含量

Key words:  ultra high performance liquid chromatography  drug substance  tildipirosin and its isomers  content

摘要:

本实验建立超高效液相色谱法（UPLC）测定泰地罗新原料药中泰地罗新及其异构体的含量。采用ACQUITY UPLC BEH C18色谱柱(2.1 mm×100 mm，1.7 μm)，流动相为0.05 mol/L磷酸氢二钾缓冲液（磷酸调pH值至8.2）-乙腈（45：55），检测波长289 nm，流速 0.5 mL/min，柱温:40 ℃，进样量:1 μL。通过光谱图、保留时间和峰面积参数对泰地罗新进行定性、定量检测。泰地罗新在0.2-2.4mg/mL 的范围内呈良好的线性关系（R2=0.9992）；方法检测限为0.2 mg/mL，定量限为0.6 mg/mL；精密度、重复性、稳定性完全满足检测需求。说明该方法快速、准确、分离度好，可快速检测泰地罗新原料药中泰地罗新及其异构体的含量。

Abstract:

In this experiment，an ultra-high performance liquid chromatography （UPLC）was established to determine the content of tildipirosin and its isomers in the raw drug of tildipirosin. Using ACQUITY UPLC BEH C18 column（2.1 mm × 100 mm，1.7 μ m），the mobile phase was 0.05 mol/L potassium hydrogen phosphate buffer solution（adjust the pH value of phosphoric acid to 8.2）-acetonitrile（45:55），the detection wavelength was 289 nm，the flow rate was 0.5 mL/min，the column temperature was 40 ℃，and the injection amount was 1 μ L. Qualitative and quantitative detection of tildipirosin was carried out by means of spectrogram，retention time and peak area parameters. Tildipirosin has a good linear relationship in the range of 0.2-2.4 mg/mL （R2=0.9992）.The detection limit of the method was 0.2 mg/mL，and the quantitative limit was 0.6 mg/mL.The precision，repeatability and stability fully met the detection requirements. It showed that the method was fast，accurate and has good resolution.It could be used for rapid determination of the content of tildipirosin and its isomers in the raw drug of tildipirosin.