Objective: The aim of the study was to compare the influence of mobile phase composition and temperature on chiral separation of racemic ibuprofen by capillary electrophoresis and high performance liquid chromatography with UV detection.
Materials and methods: Racemic ibuprofen was analysed on a chiral OVM column with an HPLC system 1100 Agilent Technologies, under isocratic elution, by using potassium dihydrogen phosphate 20 mM and ethanol in mobile phase. The flow rate was set at 1 mL/min, UV detector at 220 nm and different column temperatures were tested. For electrophoresis separation an Agilent CE G1600AX Capillary Electrophoresis System system, with UV detection, was used. The electrophoresis analysis was performed at different pH values and temperatures, with phosphate buffer 25 mM and methyl-β-cyclodextrin as chiral selector.
Results: The chromatograhic analysis reveals a high influence of mobile phase pH on ibuprofen enantiomers separation. An elution with a mixture of potassium dihydrogen phosphate 20 mM pH=3 and ethanol, at 25ºC, allowed enantiomers separation with good resolution in less than 8 min.
Conclusions: The proposed HPLC method proved suitable for the separation of ibuprofen enantiomers with a good resolution, but the capillary electrophoresis tested parameters did not allow chiral discrimination.
Tag Archives: ibuprofen
Internal Structure Quality Control of Solid Pharmaceuticals. A Comparative Study
Objective: The aim of the study was a comparative investigation by spectral and thermal analysis in order to asses a number of characteristics of different varieties ofrawmaterials of ursodeoxycholic acid and ibuprofen. The different dissolution behavior of two ursodeoxycholic acid pharmaceutical product by crystallinity pattern was investigated.
Methods: Raw materials of ursodeoxycholic acid and ibuprofen were used. IR spectroscopy, differential scanning calorimetry and X-Ray Diffraction Analysis were applied.
Results: The results show no crystallinitydifferences for different batches of the tested drugs. No solid solid transition was proved during sample preparation for transmission IR analysis.
Conclusions: A combination of two more affordabletests by IR spectrometry and differential scanning calorimetry lead to the same results as X-Ray diffraction analysis for crystallinity similarity assessment of the studied substances. The dissolution differences of test drugs were not related to the polymorphism of the raw materials.