Study on forced degradation behaviour of dofetilide by LC-PDA and Q-TOF/MS/MS: Mechanistic explanations of hydrolytic, oxidative and photocatalytic rearrangement of degradation products.

Bhargavi Thalluri,Vivek Dhiman,Shristy Tiwari, Shandaliya Mahamuni Baira,M V N Kumar Talluri

Journal of Pharmaceutical and Biomedical Analysis（2020）

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摘要

•Forced degradation studies was carried on dofetilide according to ICH Q1A (R2) guidelines.•Eight DPs were identified and separated on RP-HPLC.•Characterization of degradation products using LC-Q-TOF/MS/MS in ESI and APCI positive mode.•Mechanistic explanation and mass fragmentation pathway was established for dofetilide and its DPs.

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关键词

Dofetilide,Forced degradation study,HPLC-PDA,Degradation products,Characterization,LC–MS

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