title: Determination and validation of duloxetine hydrochloride in capsules by HPLC with pre-column derivatization and fluorescence detection.
abstract: A high-performance liquid chromatographic (HPLC) method is described for the determination of duloxetine hydrochloride in capsules. The method was based on pre-column derivatization with 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole using the fluorimetric detection technique. Duloxetine hydrochloride was analyzed by HPLC using an Inertsil C18 column (5 μm, 150 × 4.6 mm) and mobile phase consisted of methanol and water (65:35, v/v). The fluorescence detector was adjusted at excitation and emission wavelengths of 461 and 521 nm, respectively. The linearity of the method was in the range of 10-600 ng/mL. Limits of detection and quantification were 0.51 and 1.53 ng/mL, respectively. The proposed method was successfully applied for determination of duloxetine hydrochloride in its pharmaceutical preparation. The results were in good agreement with those obtained using a reference method.
authors.affiliation: Istanbul University, Faculty of Pharmacy, Department of Analytical Chemistry, 34416, Istanbul, Turkey. sevgitatar@yahoo.com
authors.forename: Sevgi
authors.initials: S
authors.lastname: Tatar Ulu
mesh_terms: D000928:Antidepressive Agents / Q000032:analysis; D002214:Capsules / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D000068736:Duloxetine Hydrochloride; D013050:Spectrometry, Fluorescence / Q000379:methods*; D013876:Thiophenes / Q000032:analysis*
chemical_list: D000928:Antidepressive Agents; D002214:Capsules; D013876:Thiophenes; D000068736:Duloxetine Hydrochloride