A novel HPLC method for simultaneous determination of trimebutine, methylparaben and propylparaben in peroral medicines

Vladimir N. Zaitsev, Oleksandr

Abstract

A simple high performance liquid chromatographic me thod has been developed and validated for the simul taneous determination of trimebutine (TB), methylparaben (M P) and propylparaben (PP) in oral medical suspensio ns. It was demonstrated that successful separation of the analytes can be achieved in isocratic condition, us ing 0.1 M aqueous monosodium phosphate buffer solution in ace tonitrile (55:45, v/v) as a mobile phase on station ary with immobilized pentafluorophenyl groups. The separatio n is observed due to specific π - π interaction of immobilized groups with analytes. The method allows to separate s TB, MP, and PP in less than 15 min with good reso lution, peak shapes and minimal tailing. Linearity ranges f or TB, MP and PP are 192–288, 22–52, 9–21 μ g/mL, respectively. The method was validated with respect to linearity, precision, accuracy, selectivity, an d robustness. The method was found to be applicable for routine a nalyzes (assays and stability tests) of bioactive c ompound (TB) and the preservatives (MP and PP).

Relevant Publications in Journal of Chemical and Pharmaceutical Research