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(-1) utilizing mobile phase as the extraction solvent. The chromatographic conditions employed a C18 column (Inertsil, 5 microm, 15 cm x 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.
Lambropoulos
J
J
Analytical Method Development and Validation, AAI, Inc., Wilmington, NC 28405, USA.
Spanos
G A
GA
Lazaridis
N V
NV
D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D005374:Filtration; D006863:Hydrogen-Ion Concentration; D007202:Indicators and Reagents; D017374:Paroxetine / Q000032:analysis*; D015203:Reproducibility of Results; D017367:Selective Serotonin Reuptake Inhibitors / Q000032:analysis*; D012996:Solutions; D013607:Tablets
D007202:Indicators and Reagents; D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors; D012996:Solutions; D013607:Tablets