Analytical Method Development, Validation Of Pitolisant Drug By Using RP-HPLC Method

Attempts to develop a robust RP-HPLC method for estimating Pitolisant in tablet form were made using an Agilent (S.K) Gradient System with a UV Detector. The C18 column employed measured 250 mm x 4.6 mm with a particle size of 5 μm. The mobile phase consisted of methanol and 0.1% water with OPA in a 45%:55% v/v ratio. Detection was carried out at a wavelength of 266 nm with a flow rate of 0.8 ml/min. The retention times for Pitolisant were found to be 3.934 and 4.627 minutes. The method was validated in accordance with ICH guidelines, demonstrating linearity over the range of 5-25 μg/ml, and precision with a value of 98.95%. The method's limit of detection (LOD) was determined to be 0.1004 μg/ml, and the limit of quantitation (LOQ) was 0.304 μg/ml. Accuracy and recovery percentages were within the 98-102% range. Additionally, the system's robustness met the criteria specified by the ICH guidelines. Therefore, the developed method is simple, accurate, precise, economical, and reproducible, making it suitable for routine quality control analysis of Pitolisant in both bulk drugs and formulations.