DEVELOPMENT AND VALIDATION OF NOVEL STABILITY-INDICATING RP-HPLC METHOD FOR DETERMINATION OF PITOLISANT IN BULK AND PHARMACEUTICAL DOSAGE FORM

A new simple, accurate and precise stability-indicating RP-HPLC analytical method has been developed and validated for the quantitative analysis of Pitolisant as bulk drug and in tablet dosage form. The objective of this study was to explore Pitolisant degradation behavior under ICH recommended stress conditions, employing a newly designed stability indicating RP-HPLC method and validating it. The method was developed on Agilent eclipse C8 (150 mm × 4.6 mm) column with Methanol: 0.05 M Phosphate Buffer (pH 5) (65: 35, v/v) as mobile phase using simple gradient elution technique. Detection was carried out at 222 nm using a photodiode array detector at ambient temperature. The retention time was found to be 3.6 min. The developed procedure was successfully validated as per ICH Q2 (R1) guidelines. The developed method was found to be linear within the range of 5-30 µg mL^-1 (R² =0.993), precise as % R.S.D. for inter-day and intra-day precision were found to be < 2 %, accurate as % recovery values in accuracy study was found to be in range of 98-102 % and sensitive as limit of detection and limit of quantitation were found to be 0.28 µg mL^-1 and 0.85 µg mL^-1, respectively.

Keywords: Pitolisant, Stress degradation, Stability indicating, RP-HPLC