1Department of Chemistry, Dr. Babasaheb Ambedkar Marathawada University, Aurangabad 431004, Maharashtra, India
2 P. G. Department of Chemistry, JES College, Jalna 431203 Maharashtra, India.
A simple, precise, accurate and linear high performance liquid chromatographic method was developed for separation and quantification of venalafaxine metabolite o-desmethylvenalafaxine. The metabolite of venalafaxine HCl was separated on a reversed phase ODS column with aq. buffer: acetonitrile (60:40) aq. buffer was prepared 0.05 MKH2P04 and add 1.0 ml triethyl amine. Resolution between the metabolite was not less than 15.0. The method was extensively validated and proved to be accurate and precise. The calibration plot was indicative of an excellent linear relationship between response and concentration over the range 0.025 ppm to 7.5 ppm for the venalafaxine metabolite. The limit of detection and quantification of the venalafaxine metabolite were 0.002 ppm and 0.006 ppm respectively for an injection volume of 20 Ill. Recovery of the venalafaxine metabolite from venalafaxine HCl samples was 92.26 %, 96.15 % and 101.15 for the 0.35%, 0.5 % and 0.6% addition. The stability of analytical solution in the diluent was studied and it was stable for 48 h. The method was found to be suitable and accurate for the quantative determination of the venalafaxine metabolite, it can be also used to test the stability samples of venalafaxine HCl. Odesmethyl venalafaxine produced as a process impurity in API of venalafaxine HCI, so this method will also used for impurity profile.
Column liquid chromatography, quantification of metabolite
