LC-HRMS/MS study on polymers in tenofovir disoproxil fumarate tablets
Objective To study the potential polymer impurities in tenofovir disoproxil fumarate tablets.Methods The samples rich in impurities(including the samples after the destructive experiment)were studied by liquid chromatography-mass spectrometry(LC-MS)with atmospheric pressure chemical ionization source(APCI ion source)and electrospray ionization source(ESI ion source),with their potential polymers found and their structures speculated.Results Dimer and trimer impurities were detected in the sample after the destructive experiment of tenofovir disoproxil fumarate tablets.Conclusion There are potential detectable polymer impurities in tenofovir disoproxil fumarate tablets:dimer and trimer impurities,among which the three impurities in the dimer are known impurities,namely H,W,and S.
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