Analytical methods for the quality control of Prozac (R) capsules

Citation
Ma. Raggi et al., Analytical methods for the quality control of Prozac (R) capsules, J PHARM B, 18(4-5), 1998, pp. 699-706
Citations number
21
Categorie Soggetti
Chemistry & Analysis
Journal title
JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
ISSN journal
07317085 → ACNP
Volume
18
Issue
4-5
Year of publication
1998
Pages
699 - 706
Database
ISI
SICI code
0731-7085(199812)18:4-5<699:AMFTQC>2.0.ZU;2-S
Abstract
Some analytical methods (two spectrophotometric and two chromatographic pro cedures) for the determination of fluoxetine in Prozac(R) capsules are desc ribed. All of them are applied to the samples after extracting the drug wit h a methanol-water mixture. The direct and derivative spectrophotometric me thods are simple and reliable; the derivative method gives better recovery and lessens interference. Both methods show linearity in the 5-30 mu g ml(- 1) range of the fluoxetine concentration range. Both HPLC methods (spectrop hotometric and spectrofluorimetric detection) use a tetramethylammonium per chlorate buffer-acetonitrile mixture as the mobile phase and a C8 reversed phase column. The UV detection is performed at 226 nm, while the fluorimetr ic detection is performed by exciting at 230 nm and revealing the emission at 290 nm. The HPLC method with UV detection is more precise, but the proce dure with fluorimetric detection is more sensitive. (C) 1998 Elsevier Scien ce B.V. All rights reserved.