The invention discloses an Fmoc-protected
amino acid purity and related substance
analysis method. The method comprises the following steps of S1, preparing an Fmoc-Osu
impurity control solution, andenabling the ratio of Fmoc-Osu to Fmoc-protected
amino acid to be (0.1-1.0): 100 to obtain an Fmoc-Osu
impurity control solution; S2, preparing a related
impurity control solution, enabling the ratioof single related impurity to Fmoc-protected amino acids to be 0.1-1.0: 1 100, obtaining a plurality of reference substance solutions, etc. According to the invention, a mobile phase, an impurity control solution and the
gradient elution conditions are comprehensively designed and optimized, the
analysis method is applied to the operation process of the
system, the baseline is smooth, no interference peak basically exists in a blank test, the impurity separation effect is prominent, and the specificity is good. The
test data shows that the
detection limit can achieve 0.002%, the sensitivity isextremely high, the detection result can provide the reliable and effective information for the research, the production and the purification of the product, the
solid foundation is established for the protected
amino acid quality control standard, and the positive effect is provided for the
quality control of the final product.