ABSTRACT

In this current investigation effort, an effort was made to build up an uncomplicated, speedy, truthful as well as robust HPLC technique for the assessment of Apremilast in its tablet dosage form. Reverse phase high performance liquid chromatographic analysis was carried out on isocratic system. The column used for the investigation was Phenomenex C18 (250 mm× 4.6mm, 5µm) with ambient temperature. The optimized mobile phase was Methanol: Acetonitrile in the ratio of (20:80 %V/V). The detection was carried out at a wavelength of 230nm using a flow rate of 1ml/min. The urbanized technique was validated for validation constraints like linearity, specificity, accuracy, precision as per ICH strategy. The %RSD for all constraints was well within the limits, which indicates the validity of the technique in addition to the assay results obtained are in reasonable conformity with the label claim of the marketed formulation. Thus, the conventional scheme can be anticipated for repetitive investigation of this drug in laboratories and for superiority purposes. Keywords: Apremilast, Acetonitrile, HPLC, Linearity
Publication date: 25/09/2021

https://ijbpas.com/pdf/2021/September/MS_IJBPAS_2021_SEPT_SPCL_1041.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.9.1041