ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF PITOLISANT HYDROCHOLRIDE API BY UV- SPECTROPHOTOMETRY

Pitolisant Hydrochloride API a Non-Pharmacopeial drug which is used to treat Narcolepsy.A simple, precise, and cost-effective UV method was developed and validated for the estimation of Pitolisant Hydrochloride API.The absorbance and spectral measurements were done on a double-beam Labindia UV-visible spectrophotometer with the software UV Win.1cm quartz cells at wavelength 221nm and the solvent system used is Methanol.The method is developed and validated for linearity, precision, robustness, stability, LOD, LOQ.The proposed UV-spectrophotometric method for estimation of Pitolisant Hydrochloride API and its validation was carried out as per ICH Q2(R1) guidelines.