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 an d related substances) of paroxetine in paroxetine hydrochloride 20 mg table ts. 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 mu m, 15 cm x 4.6 mm), isocr atic elution with 10 mM l-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. (C) 1999 Elsevier Science B.V. All rights reserved.