Author(s): VVSS Appala Raju, Ahmed Bin Mohamud, P.Janaki Pathi*, N. Appala Raju
A simple, precise, rapid and accurate reverse phase HPLC method was developed for the estimation of Trimebutine Maleate in tablet dosage form. An XTerra(R) C18 analytical column (250 x 4.6 mm, 5 μm partical size) with mobile phase consisting of mixture of buffer 0.02M Ammonium Acetate in water and acetonitrile in the gradient program was used. The flow rate was 1.0 mL/min and the effluents were monitored at 275 nm. The retention time was 17.0 minutes. The detector response was linear in the concentration of 20-300 mcg/mL. The respective linear regression equation being y = 1914.1 x -1911. The limit of detection and limit of quantification was 0.5 mcg/mL and 1.5 mcg/mL respectively. The percentage assay of Trimebutine Maleate was 99.8 %. The method was validated by determining its accuracy, precision and system suitability. The results of the study showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Trimebutine Maleate in bulk drug and in its pharmaceutical dosage form.