Objective: To establish a method for the determination of telbivudine assay by benchtop nuclear magnetic spectrometer. Methods: The 1H quantitative nuclear magnetic resonance (1H-qNMR) spectrum was determined using 1,4-dinitrobenzene as the internal standard and deuterateddimethyl sulfoxide as the solvent on a benchtop nuclear magnetic spectrometer. The assay of telbivudine was calculated by comparing the response signal of sample and internal standard. Themethod validation was accomplished. Results: The linear regression of telbivudine in the range of 10-120 mmol·L-1 was good, the RSD of injection precision was 1.2% (n=5), and the reproducible RSD was 0.35% (n=5). The result from1H-qNMR was 99.0% and was consistent with the result from mass balance method (99.6%). Conclusion: Benchtop nuclear magnetic spectrometeris compact, easy to operate and maintain. It can be used to determine the assay of telbivudine and strength the quality control of chemical drugs.
LIU Yang, ZHNAG Cai-yu, LUAN Lin, LIU Jing, ZHANG Qing-sheng
. Determination of telbivudine assay by benchtop nuclear magnetic spectrometer[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(5)
: 917
-920
.
DOI: 10.16155/j.0254-1793.2022.05.22
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