A Stability-Indicating Ultra-Performance Liquid Chromatographic Method for Estimation of Related Substances and Degradants in Paliperidone Active Pharmaceutical Ingredient and its Pharmaceutical Dosage Forms

摘要: A simple, linear gradient, rapid, precise and stability-indicating analytical method was developed for the estimation of related substances degradants paliperidone API tablets. The chromatographic separations were achieved using an Acquity ultraperformance liquid chromatograph (BEH 100 mm, 2.1 1.7 mm C-18 column) employing 0.01 M potassium dihydrogen phosphate buffer ( pH 2.0) as mobile phase acetonitrile –water (9:1) B. gradient (mobile A, B in ratio 84:16) with a 0.45 mL/min flow rate chosen. All six impurities eluted within five minutes run time. column temperature maintained at 2588C detector wavelength 238 nm employed. Paliperidone exposed to thermal, photolytic, hydrolytic oxidative stress conditions. stressed samples analyzed by proposed method. Considerable degradation analyte observed when it subjected conditions impurity F found be major degradant. Peak homogeneity data obtained photodiode array (PDA) detection demonstrated specificity presence degradants. validated respect linearity, precision, accuracy, ruggedness, robustness, limit quantification.