Development of the first national reference substance of ritonavir as a candidate drug against COVID-19

doi:10.19803/j.1672-8629.2022.02.06

Abstract

Abstract: Objective To establish the first national reference standard for determination of the content of ritonavir. Methods The structure of ritonavir was identified by means of IR, MS, ¹H-NMR and ¹³C-NMR. HPLC purity was calculated via peak area normalization, principal component self-comparison, external standard methods and response factors. The homogeneity, stability and other physicochemical properties were investigated using various analytical methods. The content was determined using the mass balance method and verified by the NMR quantitative method and differential scanning calorimeter. Results The structure of the first national reference substance of ritonavir was confirmed and its content was determined to be 99.8%. Conclusion The development of the first national reference substance of ritonavir can meet the production needs of raw materials, preparations and compound preparations of ritonavir.

Key words: ritonavir, COVID-19, reference substance, reference standard, mass balance method, quantitative nuclear magnetic resonance, DVS

CLC Number:

R969.4

XIONG Jing, LIU Yi, LIU Zhaoxia, LI Jie, ZHANG Caiyu, WU Xiangxiang, HE Lan. Development of the first national reference substance of ritonavir as a candidate drug against COVID-19[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 137-141.

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