| 摘要: |
| 建立了高效液相色谱法测定替米考星原料及其制剂的中替米考星的含量。采用C18色谱柱（4.6mm×250mm，5μm），以10%三氟乙酸-乙腈（65-35）为流动相，流速1.0 mL/min，进样量10 μL，检测波长为280 nm，柱温30℃。结果表明，当替米考星浓度为0.01～2.0 mg/mL时，替米考星顺式峰和反式峰面积和与浓度线性关系良好（R2=0.9998），无杂质干扰，重复性、稳定性和精密度的相对标准偏差＜0.8%，检出限为0.8 μg/mL，替米考星顺式峰和反式峰的分离度符合规定，顺-8-差向异构体能够实现良好分离。该方法操作简便，准确度高，重复性好，提高了替米考星及其制剂质量控制的检测效率，为其质量标准的改进提供了依据。 |
| 关键词: 高效液相色谱法 含量测定 抗生素 替米考星 |
| DOI： |
| 投稿时间：2021-03-02修订日期：2021-08-03 |
| 基金项目:北京市科学技术协会青年人才托举工程项目 |
|
| Improved Method for Determination of Tilmicosin |
|
| (China Institute of Veterinary Drug Control) |
| Abstract: |
| A method was established for the determination of tilmicosin and it preparations, including premix, injection, and solution by the high-performance liquid chromatography. C18 column was applied (4.6mm×250mm，5μm) with the mobile phase consisting of 10% trifluoroacetic acid-acetonitrile (65-35) at a flow rate of 1.0 mL/min. The injection volume was 10 μL, the detective wavelength was 280 nm, the column temperature was 30℃.The results showed a good linear relationship was accepted in the range of 0.01～2.0 mg/mL (R2=0.9998). The RSDs of precision, stability, and reproducibility were lower than 0.8%. The limit of detection was 0.8 μg/mL. The resolution between cis-form and trans-form tilmicosin was more than 1.5. Moreover, the cis-8-epimeride could be separated effectively. This method could improve the detective efficiency with convenient operation, high accuracy, and good reproducibility, which provides methodological basis for improving and promoting the quality standards. |
| Key words: high-performance liquid chromatography determination antibiotics tilmicosin |
