An LC-MS/MS Approach for the Identification of Degradation Products of Serdexmethylphenidate and Dexmethylphenidate and Elucidation of their Degradation Pathway
Gowri Gollu, Sowjanya Gummadi, Santosh Kumar Sahoo, Jagadeesh PandaBackground/Objective:
A combination of serdexmethylphenidate and dexme-thylphenidate is used to treat attention deficiency hyperactivity disorder. A stability-indicating RP-HPLC method has been developed and reported in the literature. As there is no study on the degradation product identification, in this work, the degradation behavior of serdexmethylpheni-date and dexmethylphenidate was explored by subjecting combined dosage to the forced degrada-tion study by applying the developed RP-HPLC method. Further, plausible structures and frag-mentation patterns of all the degradation products were identified by the LC-MS/MS study.
Methods:
The forced degradation study was conducted by exposing the combined dosage form (Azstarys) as per International Council of Harmonization (ICH) guideline Q1A (R2). Using LC-MS/MS, MS spectra were obtained. Based on the m/z values and molecular formula, probable structures of degradation products were elucidated.
Results:
A total of 7 degradation products were detected, of which, 4 degradation products were formed from serdexmethylphenidate. The remaining 3 degradation products were formed from dexmethylphenidate. The possible structures and fragmentation patterns of all the degradation products were examined with the help of the LC-MS/MS study.
Conclusion:
As possible structures and fragmentation patterns were identified by the LC-MS/MS study, this method may help in the development of quality dosage forms, maintaining proper stor-age conditions, and also in impurity profiling studies.