Abstract
CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION OF ASSAY OF APREMILAST IN BULK AND TABLET DOSAGE FORM

Rina Mohan Sonawane*, Rutuja Prabhakar Sonare, Snehal Ganpat Tekawade and Dr. Ashok Pandurang Pingle

ABSTRACT

The present work describes development and validation of a simple, sensitive, precise, accurate and specific reverse phase high performance liquid chromatographic method for analysis of Apremilast, as bulk drug. Apremilast is used to treat psoriatic arthritis. The separation was achieved by using a mobile phase of Methanol: Water (80:20, v/v) on a Grace C18 column (250mm x 4.6ID, 5μm) at flow rate of 0.8 ml/min. The detection was done at 231 nm. The retention time of Apremilast was 4.80 minutes. Calibration plot was linear (r2=0.9998) over a range of 2-5μg/ml. The method was validated for linearity, accuracy, precision, robustness and recovery. The proposed method was successfully used for quantitative determination of Apremilast. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Apremilast in tablet dosage form.

Keywords: Apremilast, RP-HPLC, Validation.


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