Method development and validation for the HPLC assay (potency and related substances) for 20 mg paroxetine tablets

A reversed phase high performance liquid chromatographic (HPLC) method was developed and validated for use as a stability indicating assay (potency and related substances) of paroxetine in paroxetine hydrochloride 20 mg tablets. Assay samples were extracted at a paroxetine concentration of 0.4 mg ml...

Full description

Saved in:
Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 1999-04, Vol.19 (5), p.793-802
Main Authors: Lambropoulos, John, Spanos, George A., Lazaridis, Nick V.
Format: Article
Language:English
Subjects:
Analysis
Assay
Biological and medical sciences
Chromatography, High Pressure Liquid
Development
Dissolution
Drug Stability
Filtration
General pharmacology
Hydrogen-Ion Concentration
Indicators and Reagents
Liquid chromatography
Medical sciences
Paroxetine
Paroxetine - analysis
Pharmacology. Drug treatments
Potency
Related substances
Reproducibility of Results
Serotonin Uptake Inhibitors - analysis
Solutions
Tablets
Validation
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:A reversed phase high performance liquid chromatographic (HPLC) method was developed and validated for use as a stability indicating assay (potency and related substances) of paroxetine in paroxetine hydrochloride 20 mg tablets. Assay samples were extracted at a paroxetine concentration of 0.4 mg ml −1 utilizing mobile phase as the extraction solvent. The chromatographic conditions employed a C 18 column (Inertsil, 5 μm, 15 cm×4.6 mm), isocratic elution with 10 mM 1-decane sulfonic acid sodium salt containing 10 mM sodium phosphate monobasic (pH 3.0)–ACN (60:40, v/v) and ultraviolet (UV) detection at 235 nm.
ISSN:0731-7085
1873-264X
DOI:10.1016/S0731-7085(98)00309-4