建立了Y101中间体N-(N-苯甲酰基-O-苯甲酰基-L-酪氨酰基)-L-苯丙氨醇(M057)及其已知杂质的含量测定方法。采用液相色谱质谱联用技术(HPLC/MS),正离子扫描模式指认杂质峰;采用高效液相色谱(HPLC)外标法,以甲醇-水(v∶v=75∶25)洗脱,测定M057含量,以甲醇-0.01%磷酸水溶液梯度洗脱,测定3个已知杂质含量。测定结果:M057含量不低于77%,已知杂质总量未超过4.5%。本法已作为该中间体质量内控方法。 A method for the determination of the content of Y101 intermediate N- (N-benzoyl-O-benzoyl-L-tyrosyl) -L-phenylalaninol (M057) and its known impurities was established. The impurity peaks were identified by LC / MS and positive ion scan mode. The compounds were eluted with methanol-water (v:v:75:25) by HPLC, The content of M057 was determined and eluted with a gradient of methanol-0.01% phosphoric acid aqueous solution to determine the content of three known impurities. Measurement results: M057 content of not less than 77%, the total amount of impurities is not known to exceed 4.5%. This Law has been used as the quality control method for this intermediate.