வேதியியல் அறிவியல் இதழ்

LC–MS/MS Characterization of Forced Degradation Products of Tetrabenazine

Abstract

Swetha Parsha, Ravindra Kumar Y and Ravichander M

A rapid, precise and reliable LC-MS/MS method has been developed for the identification and characterization of stressed degradation products of Tetrabenazine. Tetrabenazine is a drug, for the symptomatic treatment of hyperkinetic movement disorder. Tetrabenazine works mainly as a VMAT inhibitor. It promotes the early metabolic degradation of monoamines, in particular the neurotransmitter dopamine. Tetrabenazine was subjected to hydrolysis acidic, alkaline, neutral peroxidation, light and thermal stress conditions as per ICH-specified conditions. The drug showed degradation under peroxidation, thermal, acid and base hydrolysis stress conditions. However, it was stable to neutral stress conditions and light degradation. A total of 4 degradation products were observed and the chromatographic separation of the drug and its degradation products were achieved on Inertsil ODS-3V 150 mm × 4.6 mm, i.d., 5 μm column using 0.01 M ammonium acetate and ACN in the ratio of 640:360 as mobile phase-A and 900:100 ratio of ACN:Water as mobile phase –B. The degradation products were characterized by LC–MS/MS and its fragmentation pathways were proposed. Probable possible structures were drawn based on parent and daughter molecular ions.