Objective: To establish the first national reference standard of beinaglutide. Methods: TOF-MS, N-terminal sequence determination, ratio coefficient of amino acid, peptide mapping were used to confirm the structure of beinaglutide. The purity was determined by HPLC. The content of active pharmaceutical ingredients A(API,sample of large size) was determined by mass balance method. Using API A as reference substance, the content of API B(candidate standard) was determined by HPLC external standard method. The potency of API B was determined by cell culture in vitro. Andthe stability and uniformity of API B(the candidate preparation) were investigated. Results: The structure of the beinaglutide was confirmed, the content of the first beinaglutide natio-nal reference standard was assigned as 0.932 mg per ampoule and the potency was 1.0×104 U per ampoule. The purity of API B(candidate preparation) was not significantly decreased when it was placed at 4 ℃ or 25 ℃, RH 80% for 10 d, and the purity was significantly decreased when it was exposed to light for 10 d. RSD of 15 API B(candidate standard) was 0.86%, showing good homogeneity. Conclusion: The first batch of national standard beinaglutide could be used for HPLC identification, content determination and biological activity determination of benalutide and related preparations of beinaglutide.
DING Xiao-li, LÜ Ping, CAI Yong-qing, DUAN Xu-hua, WANG Lü-yin, CHEN Ying, XU Ke-zheng, LI Jing, ZHANG Wei, HU Xin-yue, LI Yi, SUN Yue, ZHANG Hui, LIANG Cheng-gang
. Development of the first national reference standard of beinaglutide*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(1)
: 78
-85
.
DOI: 10.16155/j.0254-1793.2022.01.09
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