Lambropoulos J, Spanos G A, Lazaridis N V
Analytical Method Development and Validation, AAI, Inc., Wilmington, NC 28405, USA.
J Pharm Biomed Anal. 1999 Apr;19(5):793-802. doi: 10.1016/s0731-7085(98)00309-4.
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.
建立并验证了一种反相高效液相色谱（HPLC）方法，用于盐酸帕罗西汀20mg片剂中帕罗西汀的稳定性指示测定（效价和有关物质）。采用流动相作为萃取溶剂，在帕罗西汀浓度为0.4mg/ml的条件下对测定样品进行萃取。色谱条件为：使用C18柱（Inertsil，5μm，15cm×4.6mm），以含10mM磷酸二氢钠（pH3.0）的10mM癸烷磺酸钠-乙腈（60:40，v/v）进行等度洗脱，并在235nm波长处进行紫外（UV）检测。
