Utilizing quality by design methodology for liquid chromatography method development and validation in quantifying impurities in Pitolisant, a Histamine-3 (H3) receptor antagonist/inverse agonist

Utilizing quality by design methodology for liquid chromatography method development and validation in quantifying impurities in Pitolisant, a Histamine-3 (H3) receptor antagonist/inverse agonist

We developed and validated a liquid chromatography technique to determine organic impurities of Pitolisant in Pitolisant film-coated tablets (4.45 mg and 17.8 mg), a medication used to treat excessive daytime drowsiness. The method uses a gradient elution process on an Inertsil ODS-3 V column (250 m...

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Bibliographic Details
Main Authors: Jayaprakash Kanijam Raghupathi, Lova Gani Raju Bandaru, Kiran Kumar Madineni, Mastan Ali Syed, Sreekantha Babu Jonnalagadda, D. Ramachandran, Naresh Kumar Katari
Format: Article
Language:English
Published: Elsevier 2025-07-01
Series:Results in Chemistry
Subjects:
Pitolisant
Impurities
HPLC
Method validation
Design of experiments
Factorial design
Online Access:http://www.sciencedirect.com/science/article/pii/S2211715625003339
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