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

This paper describes the development and validation of a high performance liquid chromatography (HPLCUV) 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 (250x4.6 mm i.d.; 5 mu m particle size) using a mobile phase consisting of 80:20 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 210 nm for artemether and 286 nm for lumefantrine. The retention times were similar to 5.8 mins for artemether and similar to 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 %.