ABSTRACT

This study presents the development and validation of a reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of pitolisant, a novel treatment for narcolepsy. Narcolepsy is a chronic neurological condition that causes excessive daytime drowsiness and other severe symptoms. Pitolisant drug was purchased as a synthetic mixture and the separation was accomplished with C18 (250 mm 4.6 mm, 5?m spherical particles) column. The mobile phase contains mobile phase A- 10mm ammonium acetate buffer calibrated to pH 4 and mobile phase B- as acetonitrile in a gradient mode at a wavelength 268nm. The flow rate of the mobile phase and the sample volume injected were 1ml/min and 10L, respectively. Pitolisant had a retention time of 4.4±0.2 minutes. Pitolisant showed a linear association (R2=0.999) over concentrations ranging from 22.5?g to 360?g. Validation studies confirmed the method's reliability, accuracy, precision, linearity, and sensitivity, making it suitable for regular examination in quality control laboratories. The validated method will aid drug manufacturers, regulatory agencies, and researchers in assessing pitolisant's content in pharmaceutical formulations and pharmacokinetic studies, ultimately benefiting narcolepsypatients. The devised approach is simple, precise, specific, accurate, and fast, making it appropriate for estimating pitolisant in bulk and pharmaceutical dose form. It was found that the current RP-HPLC technology is simple, quick, and accurate, and hence suitable for routine quality control analysis in the pharmaceutical business. Keywords: pitolisant, Narcolepsy, Validation, HPLC
Publication date: 01/02/2025

https://ijbpas.com/pdf/2025/February/MS_IJBPAS_2025_8713.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.2.8713