PITOLISANT HCl: A REVIEW ON DRUG CHARACTERISTICS AND COMPARATIVE HPLC METHOD DEVELOPMENT AND VALIDATION
Vignesh J.*, Murugan S. and Vetrichelvan T.
ABSTRACT
Pitolisant, a selective histamine H3 receptor antagonist/inverse agonist, is an innovative therapeutic agent for treating narcolepsy and related disorders of excessive daytime sleepiness. The review focuses on the development and validation of high-performance liquid chromatography methods and analysis of pitolisant in pharmaceutical formulations and bulk, critical aspects of HPLC method development, including the selection of mobile phase, stationary phase, flow rate and detection parameters, are examined to achieve optimal separation and sensitivity. This work aims to provide a comprehensive resource for researchers and analysts to ensure the quality control and regulatory compliance of pitolisant, contributing to its therapeutic efficacy and safety in clinical applications.
Keywords: Pitolisant, HPLC, Method development, validation.
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