Abstract:

New methods were developed for the determination of succinic acid in desvenlafaxine succinate (DVS) by high performance ion-exclusion chromatography (HPIEC) and high performance ion-exchange chromatography (HPIC). HPIEC and HPIC methods were used separately to determinate the succinic acid in DVS. With HPIEC, the sample was diluted with 2.50×10^-3mol/L sulfuric acid solution and filtrated by 0.22 μ m polyether sulfone filter membrane, and then analyzed by HPIEC directly without any further pretreatment. The analytical column was Phenomenex Rezex ROA-organic Acid H+(8%)(300 mm×7.8 mm). The mobile phase was 2.50×10^-3mol/L sulfuric acid solution at the flow rate of 0.5 mL/min. The column temperature was set at 40 ℃, and the detection wavelength was 210 nm. The injection volume was 10 μ L. The assay was quantified by external standard method. With HPIC, the sample was diluted with ultrapure water and filtrated by 0.22 μ m polyether sulfone filter membrane, and then analyzed by HPIC directly without any further pretreatment. The analytical column was Dionex IonPac AS11-HC (250 mm×4 mm) with a guard column IonPacAG11-HC (50 mm×4 mm). Isocratic KOH elute generator was used at the flow rate of 1.0 mL/min. The detection was performed by a Dionex suppressed (DIONEX AERS 500 4-mm) conductivity detector. The injection volume was 10 μ L. The content computation was performed with peak area external reference method. The results of HPIEC method for succinic acid were 28.8%, 28.9% and 28.9%, while the results of HPIEC method were 28.2%, 28.6% and 28.6%. The results of HPIEC and HPIC methods were not significantly different. The two methods can both be used to determine the contents of succinic acid in DVS. The surveillance analytical method should be chosen according to the situation.

Key words: desvenlafaxine succinate (DVS), high performance ion-exchange chromatography, high performance ion-exclusion chromatography (HPIEC), succinic acid