Stability-Indicating HPLC Methods for Determination of Assay and Related Substances in Novel Orodispersible Meclizine Hydrochloride Tablet
Abstract
Orodispersible tablets (ODT) constitute an innovative dosage form which provides a patient-friendly option that enhances compliance and therapeutic convenience, particularly for pediatric and geriatric populations with swallowing difficulties. Meclizine ODT (6.25 mg and 12.5 mg) have been developed at F1 Pharma S.A., packaged in blisters and designed for stability studies. This study reports the development and full validation in compliance with ICH Q2(R1) guidelines of two HPLC methods for the quantification of meclizine hydrochloride and its related impurities in the 6.25 mg ODT formulation. Both methods proved highly specific, precise, accurate, and robust, with validated working ranges suitable for routine quality control and stability testing. Forced degradation experiments identified impurities C and H as the primary degradation products. Long-term stability studies conducted under ICH Zone II and III conditions confirmed chemical stability of the formulation, with assay values consistently within ±5% of label claim and impurity levels within acceptable limits. The developed novel ODT formulation meets all regulatory requirements, while validated HPLC methods ensure reliable routine analysis, supporting quality control and stability studies of this innovative dosage form, which enhances patient comfort and treatment effectiveness.
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