HPLC (High Performance Liquid Chromatography) determination method for liraglutide injection related substances

The invention discloses an HPLC (High Performance Liquid Chromatography) determination method for liraglutide injection related substances, which is characterized in that a monopotassium phosphate buffer solution-acetonitrile is used as a mobile phase, and the liraglutide injection related substances are determined by a main component self-contrast method under proper ultraviolet detection wavelength and flow velocity. According to the method, the related substances can well achieve baseline separation, and the content of the liraglutide related substances can be accurately determined. The method is simple, rapid, accurate, efficient and good in reproducibility, and a good foundation is established for formulating the quality standard of the liraglutide injection. 本发明公开一种利拉鲁肽注射液有关物质的HPLC测定方法，该方法采用磷酸二氢钾缓冲液-乙腈作为流动相，在适当的紫外检测波长和流速下，通过主成分自身对照法测定利拉鲁肽注射液的有关物质。该方法能够使有关物质很好的达到基线分离，能够准确测定利拉鲁肽有关物质的含量。该方法简单、快速、准确、高效，重现性好，为利拉鲁肽注射液质量标准的制定建立了良好的基础。