Research Article

Fast Stability Indicating UPLC Method for Quantitative Analysis of Dronedarone in Pharmaceutical Dosage Form: Force Degradation Study

Table 2

Summery of mobile phase optimization.

Solvent ASolvent BRemarks

Water
AcetonitrileVery broad peak with peak splitting
5 mM ammonium acetateMethanolBroad peak with peak tailing
5 mM ammonium acetateAcetonitrileBroad peak with peak tailing
1% orthophosphotic acid (OPA) in waterAcetonitrilePeak eluted early with peak tailing
5 mM potassium dihydrogen phosphate (pH = 2.5 by OPA)MethanolBroad peak with peak tailing
5 mM potassium dihydrogen phosphate (pH = 2.5 by OPA)AcetonitrileBroad peak with peak tailing
5 mM potassium dihydrogen phosphate + 1 mL triethylamine (TEA) (pH = 2.5 by OPA)MethanolGood peak shape but retention time precision fail
20 mM potassium dihydrogen phosphate + 1 mL triethylamine (TEA) (pH = 2.5 by OPA)MethanolGood peak shape with good precision