Objective: To identify the related substances in aciclovir tablets by LC-Q-TOF/MS. Methods: The separation of the related substances in aciclovir tablets were carried out on an ODS (250 mm×4.6 mm,5 μm) column with gradient elution using 0.15% formic acid 10 mmol·L-1 ammonium formate buffer solution and acetonitrile as mobile phases. The accurate mass and elemental composition of the parent ions and their product ions of the related substances were determined by electrospray-ionization quadrupole time-of-flight high resolution mass spectrometry. The structures of the related substances were elucidated. Results: Under the established LC-Q-TOF/MS condition, aciclovir and its related substances were adequately separated, and 23 major related substances including 7 known impurities specified in the EP were detected and identified in aciclovir tablets and its stressed samples. Conclusion: The results can provide reference for the quality control of aciclovir tablets.
WANG Li-jie, LIN Dong-xiang, ZHU Mi-qun, LU Yu-ting, SONG Min, HANG Tai-jun
. Identification of the related substances in aciclovir tablets by LC-Q-TOF/MS*[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(8)
: 1381
-1393
.
DOI: 10.16155/j.0254-1793.2023.08.14
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