Nov 30, 2019

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

Journal of Pharmaceutical and Biomedical Analysis
Bhargavi ThalluriM V N Kumar Talluri


A solution and solid state forced decomposition study was carried on dofetilide under diverse stress conditions of hydrolysis, oxidation, photolysis and thermal as per International Council for Harmonisation guidelines (ICH) Q1A(R2) to understand its degradation behaviour. A total of eight degradation products (DPs) were identified and separated on reversed phase kromasil 100 C8 column (4.6 mm x 250 mm x5 μm) using gradient elution with ammonium acetate (10 mM, pH 6.2) and acetonitrile as mobile phase. The detection wavelength was selected as 230 nm. The high performance liquid chromatography (HPLC) study found that the drug was susceptible to hydrolytic stress condition, but it was highly unstable to photolytic and oxidative conditions. The solid drug was stable in thermal and photolytic conditions. Initially comprehensive mass fragmentation pattern of the drug was accomplished with the LC/ESI/QTOF/MS/MS studies in positive ionization mode. The same was followed for all the eight degradation products to characterise their structure. The DP4 was N-oxide and the structure was confirmed by LC/APCI/QTOF/MS/MS in positive ionization mode. The complete mass fragmentation pattern of the drug and its DPs were established which in turn...Continue Reading

  • References
  • Citations


  • We're still populating references for this paper, please check back later.
  • References
  • Citations


  • This paper may not have been cited yet.

Mentioned in this Paper

TOF MS (Time of Flight Mass Spectrometry)
RFX5 gene
Pharmacologic Substance
High Pressure Liquid Chromatography Procedure
Ammonium acetate

Related Feeds

Anti-Arrhythmic Drug Therapies

Anti-arrhythmic drugs are used to prevent abnormal heart rhythms. These medications are used in conditions including, ventricular tachycardia, ventricular fibrillation and atrial fibrillation. Discover the latest research on anti-arrhythmic drug therapies here.