Abstract
Objective An attempt was made to develop a simple, isocratic and robust reverse phase high performance liquid chromatographic method for Pitolisant. Material and methods An Inertsil octa decyl silane column and photo diode array detector were employed for the quantification of Pitolisant at 268 nm using a mobile phase consisting of acetonitrile and 0.1 % v/v formic acid (90:10 % v/v) at a flow rate of 1.0 mL/min. for the efficient elution of Pitolisant. Results The developed method was validated for various parameters and the linearity range was observed at 25-150 µg/mL. The correlation coefficient, limit of detection and limit of quantification calculated from the calibration curve were 0.9998, 0.3 µg/mL and 1.0 µg/mL respectively. The mean percentage recovery was 99.9 %. The formulation was subjected to stress at various conditions resulting in minor degradants at different retention times. Conclusion An isocratic, fast, robust reverse phase – high performance liquid chromatographic method was developed which can be exploited for the estimation of Pitolisant in bulk and tablets. Key words: Pitolisant, High performance liquid chromatography, Photo diode array detector, Limit of detection, Degradation studies
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