Assay validation for three antidepressants in pharmaceutical formulations: Practical approach using capillary gas chromatography.

摘要

An easy and fast capillary gas chromatographic FID method, which was already described by the same authors for the simultaneous determination of fluoxetine, fluvoxamine and clomipramine without derivatization step, is now submitted to a validation procedure in several pharmaceutical formulations. Main aspects of the validation method are examined and discussed, since methods for regulatory submission in most cases must demonstrate: specificity in presence of all potential components, concentration range over which the response is lineal, accuracy, precision, acceptable detection and quantitation limits and stability of the procedure. The pharmaceutical preparations subject of validation were: 'Prozac' (capsules), 'Dumirox' (tablets) and 'Anafranil' (tablets) containing fluoxetine, fluvoxamine and clomipramine, respectively. The results presented in this report show the applied gas chromatographic method is acceptable for the determination of the three antidepressants in the pharmaceutical formulations above mentioned.