Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2018 Vol: 10 Issue: 7

Reversed Phase High Performance Liquid Chromatography Method for Determination of Assay and Forced Degradation Study of Apremilast from Active Pharmaceutical Dosage Form


A new and accurate high performance liquid chromatography method is developed for determination of apremilast from active pharmaceutical ingredients. An inertsil C8 (250 X 4.6 mm) 5μ column is used for assay of apremilast. The mixture of buffer and methanol (47:53 % v/v) is used as mobile phase. The buffer made up of 0.1% orthophosphoric acid in water adjusted pH 2.8 with potassium hydroxide. The detector wavelength set at 230 nm. The mixture of buffer and acetonitrile (70:30% v/v) was used as a diluent. As per ICH guidelines, the method was validated containing parameter of system suitability, linearity, accuracy, precision, robustness, stability of sample solution. The method has been successfully used to analyze apremilast from active pharmaceutical ingredients.