A simple, rapid, precise, sensitive and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the quantitative analysis of Pitolisant in pharmaceutical dosage form. Chromatographic separation of Pitolisant was achieved on Waters Alliance-e2695, by using Waters X-Bridge Phenyl, 150mm x 4.6mm, 3.5µm, column and the mobile phase containing 0.1% OPA& ACNin the ratio of 30:70% v/v. The flow rate was 1.0 ml/min; detection was carried out by absorption at 210nm using a photodiode array detector at ambient temperature. The number of theoretical plates and tailing factor for Pitolisant was NLT 2000 and should not more than 2respectively. %Relative standard deviation of peak area of all measurements always less than 2.0. The proposed method was validated according to ICH guidelines. The method was found to be simple, economical, suitable, precise, accurate & robust method for quantitative analysis of Pitolisant and study of its stability.
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