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  • Development and validation of a method for the analysis of paroxetine HCl by circular dichroism.

Development and validation of a method for the analysis of paroxetine HCl by circular dichroism.

Chirality (2013-03-28)
Zenaide S do Monte, Clécio S Ramos
ABSTRACT

A simple, rapid, and sensitive method for the analysis of paroxetine, in tablets as well as the pure drug, by circular dichroism is described. The method was validated for repeatability, linearity, limit of detection, limit of quantification, and recovery according to the International Conference on Harmonization guidelines. Excellent results were obtained, within the globally accepted validation reference values, particularly taking into account the low concentration levels investigated. This is the first report of the quantitation of paroxetine, a chiral drug, without previous separation of the analyte. Additionally, the solid state CD spectrum of PXT was obtained.

MATERIALS
Product Number
Brand
Product Description

Paroxetine for system suitability, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Paroxetine maleate salt, ≥98% (HPLC), solid
Sigma-Aldrich
Paroxetine hydrochloride hemihydrate, ≥98% (HPLC), powder
Paroxetine hydrochloride hemihydrate, European Pharmacopoeia (EP) Reference Standard
Supelco
Paroxetine maleate solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material, Cerilliant®