Determination and Validation of Duloxetine Hydrochloride in Capsules by HPLC with Pre-Column Derivatization and Fluorescence Detection

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...

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Published inJournal of chromatographic science Vol. 50; no. 6; pp. 494 - 498
Main Author Tatar Ulu, Sevgi
Format Journal Article
LanguageEnglish
Published Niles, IL Oxford University Press 01.07.2012
Preston Publications
Subjects
Adjustment
Analysis
Antidepressive Agents - analysis
Biological and medical sciences
Capsules - analysis
Chromatography
Chromatography, High Pressure Liquid - methods
Duloxetine Hydrochloride
Emission
Fluorescence
General pharmacology
Hydrochlorides
Liquids
Medical sciences
Methyl alcohol
Pharmacology. Drug treatments
Spectrometry, Fluorescence - methods
Thiophenes - analysis
Wavelengths
Validation
Fluorescence detector
Chemical analysis
Serotonin
Precolumn
Psychotropic
HPLC chromatography
Oral form
Duloxetine
Reuptake inhibitor
Derivatization
Fluorescent labelling
Dosage form
Antidepressant agent
Hard capsule
Quantitative analysis
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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.
AbstractList 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.
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 mu m, 150 x 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.
Author Tatar Ulu, Sevgi
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Issue 6
Keywords Validation
Fluorescence detector
Chemical analysis
Serotonin
Precolumn
Psychotropic
HPLC chromatography
Oral form
Duloxetine
Reuptake inhibitor
Derivatization
Fluorescent labelling
Dosage form
Antidepressant agent
Hard capsule
Quantitative analysis
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SubjectTerms Adjustment
Analysis
Antidepressive Agents - analysis
Biological and medical sciences
Capsules - analysis
Chromatography
Chromatography, High Pressure Liquid - methods
Duloxetine Hydrochloride
Emission
Fluorescence
General pharmacology
Hydrochlorides
Liquids
Medical sciences
Methyl alcohol
Pharmacology. Drug treatments
Spectrometry, Fluorescence - methods
Thiophenes - analysis
Wavelengths
Title Determination and Validation of Duloxetine Hydrochloride in Capsules by HPLC with Pre-Column Derivatization and Fluorescence Detection
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