标题:Method development and validation for the HPLC assay (potency and related substances) for 20 mg paroxetine tablets
作者:John Lambropoulos, George A. Spanos and Nick V. Lazaridis
杂志:Journal of Pharmaceutical and Biomedical Analysis Volume 19, Issue 5, April 1999, Pages 793-802
摘要: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 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.