Oxcarbazepina: desenvolvimento e Validação de métodos analíticos deControle de qualidade. Aplicação em Formulações magistrais.

Abstract

Oxcarbazepine, an anticonvulsant drug, is a keto analog of carbamazepine, which has an improved tolerability, safety and pharmacokinetic profile compared to carbamazepine. Because of the low therapeutic index of this drug, the quality control of formulation containing oxcarbazepine is essential to manufacture pharmaceutical dosage forms with efficacy, safety and quality requirements. The objective of thisresearch is to determine quality parameters for oxcarbazepine, raw material and compounded capsules, and to establish a standard formulation. An ultraviolet absorption spectrophotometric method was development and validated for assay of oxcarbazepine raw material and compounded capsules. The method presented specificity, linearity, precision, accuracy and robustness and is viable of being appliedin a compounding pharmacy. A high performance liquid chromatography method was adapted and validated for the oxcarbazepine assay for raw material and presented specificity, linearity, precision, accuracy, robustness and adequate limits of detection and quantification. Three formulations of oxcarbazepine capsules were developed, by a proposed and validated process of compounding, and evaluated for characteristics such flowability, weight variation, disintegration time, assay, uniformityof content and dissolution. The comparative release profile contributed to evaluate the influence of the mixture of excipientes in the dissolution of oxcarbazepine.