Development and evaluation of levocetirizine dihydrochloride oral wafers and validation of RP-hplc method

Motwani A. N., Sawale A. V., Vyas L. K., Hole G. A., Shelke S. U., Pachghare B. P., Pote S. S.

International Journal of Drug Delivery Technology, 2026

Abstract

Levocetirizine dihydrochloride is a widely used antihistaminic agent, but its bitter taste and need for rapid action

highlight the demand for patient-friendly oral dosage forms. The present study aimed to develop fast-dissolving

oral wafers of levocetirizine dihydrochloride and to validate a simple RP-HPLC method for its quantitative

estimation in the formulation. Oral wafers were prepared by solvent casting using suitable film-forming

polymers and evaluated for physicochemical properties, drug content, and in vitro drug release. Among the

prepared batches, F1 showed the best overall performance, with acceptable mechanical strength and the highest

drug release. The RP-HPLC method was developed and validated in accordance with ICH Q2(R2) principles for

specificity, linearity, accuracy, precision, and robustness. The method exhibited excellent linearity, accuracy,

and precision. The study suggests that the optimized oral wafer formulation may improve patient compliance,

while the validated analytical method is suitable for routine quality control of levocetirizine oral wafers.

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