摘要
目的:建立高效液相色谱法测定盐酸林可霉素的有关物质。方法:采用DiamonsilTMC18色谱柱(4.6 mm×200 mm,5μm),流动相为0.05 mol.L-1硼砂溶液(用85%磷酸溶液调节pH值至6.1)-甲醇(1∶1),紫外检测波长214 nm。结果:林可霉素与相邻杂质之间及各有关物质之间的分离度良好,最低检出限为20.16 ng,精密度为0.15%。结论:该方法简便、准确、快速、专属性强,可用于盐酸林可霉素的质量控制。
Objective： To establish an HPLC method for the determination of Lincomycin Hydrochloride for related substances by HPLC. Methods： The DiamonsilTM C ls （4. 6 mm×200mm, 5μm）. The mobile phase： 0. 05 mol·L^-1 borax solution （adjusted to pH 6. 1 with 85% phosphoric acid）-methanol （1：1 ）. Detection wavelength is 214 nm. Results： The resolution factor between peaks of lincomycin and the impurities complies with the related requirements, and the LOD of Lincomycin Hydrochloride were 20. 16 ng. Conclusion： The method is simple and rapid with high resolution.
出处
《中国药品标准》
CAS
2011年第1期54-56,共3页
Drug Standards of China
