HPLC-UV method for simultaneous quantitation of artemether and lumefantrine in fixed dose combination orodispersible tablet formulation.

ABSTRACT

This paper describes the development and validation of a high performance liquid chromatography (HPLC-UV) method for the simultaneous quantitative determination of artemether and lumefantrine in fixed dose combination tablets. Chromatographic quantitation was carried out on a C-18 column Mediterrania Sea 18 (250×4.6 mm i.d.; 5 µm particle size) using a mobile phase consisting of 8020 v/v mixture of acetonitrile and 0.05 % trifluoroacetic acid with final pH adjusted to 2.35 at flow rate of 1 ml/minute. The eluents was detected using photo diode array detector at wavelength of 210nm for artemether and 286 nm for lumefantrine. The retention times were ~5.8 mins for artemether and ~7.3 mins for lumefantrine. The newly developed method was validated and was found linear (r2 >0.99), precise (R.S.D. <2.0%), accurate, specific and robust. The artemether contents in the tablet formulation varied from 99.026 % to 99.347%, while lumefantrine contents were 99.546-99.728 %.