IAI SPECIAL EDITION: Development and validation of dissolution testing of Flunarizine dihydrochloride in tablet dosage form
DOI:
https://doi.org/10.46542/pe.2022.222.132137Keywords:
Dissolution method, Flunarizine dihydrochloride , High-performance liquid , chromatography , Hyper-discriminating, Immediate release tabletAbstract
Background: Flunarizine dihydrochloride is an antivertigo, antimigraine, and adjunctive therapy for epilepsy, available in Indonesia as tablets. However, the dissolution test for the tablet dosage forms is not yet available in the Pharmacopoeia.
Objectives: To develop and validate the dissolution method of flunarizine dihydrochloride in tablets.
Methods: The dissolution profiles of three products were determined using three media (HCl 0.1N, acetate buffer pH 4.5, and 0.2% Tween 80 solution); two apparatus (basket and paddle); at three agitation speeds (50, 75, and 100rpm). The amount of drug released per unit time was measured by a validated High Performance Liquid Chromatography system.
Results: The method using a paddle apparatus at 50rpm in 900mL of 0.1N HCl medium was better hyperdiscriminating with a Q30 value ≥ 75% (p < 0.05). The selected method met the acceptance criteria in terms of precision, accuracy, and specificity.
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