Stability-Indicating Estimation of Pitolisant in Pharmaceutical Formulations Using RP-HPLC: Method Development and Validation

Abstract

Pitolisant in bulk and commercial formulations will be quantitatively assessed using the current, experimentally stable RP-HPLC method, which will be established and validated by this investigation. 0.2% formic acid (1mL in 500mL of water) and acetonitrile (ACN) in a 40:60 ratio is used as the mobile phase in this procedure. YMC ODS-a 150 x 4.6 mm column with 3 microns as the particle size. With a 5 µL injection volume and a 1.0 mL/min flow rate, a PDA detector calibrated at 220 nm was employed to track the elution. As per the rules set forth by the International Conference on Harmonization (ICH), the suggested technique was validated. In the 100 – 300µg/mL concentration range, the Pitolisant technique showed linearity. Results indicated a repeatable procedure and a 100.26% Pitolisant recovery. Studies on stress degradation revealed that there was no significant degradation and that the procedure was accurate. As a result, the created method is thought to be precise and appropriate for regular research applications.