2025, Vol. 5, Issue 2, Part B

Objective: The present study aimed to develop and validate a simple, cost-effective, and reliable UV-spectrophotometric method for the quantification of Pitolisant Hydrochloride in bulk and tablet formulations, in accordance with ICH guidelines.

Methods: Quantification was performed using a UV-spectrophotometer with distilled water as solvent. Pitolisant showed maximum absorbance at 221 nm (zero order) and 228 nm (first order). The linearity range was 22.25-111.25 µg/ml, with correlation coefficients (r²) of 0.9997 and 0.9998 for zero and first order, respectively.

Results: All validation parameters linearity, accuracy, precision, LOD, LOQ, and recovery were within acceptable limits, confirming the reliability of the developed methods for both zero and first order derivatives.

Conclusion: The developed UV-spectrophotometric techniques provide a straightforward, reliable, and cost-effective approach for the routine quantitative determination of Pitolisant Hydrochloride in tablet formulations.