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Abstract

DEVELOPMENT AND VALIDATION OF UV-SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF APREMILAST IN BULK FORM BY ABSORBANCE MAXIMA METHOD

N. A. Lonkar*, M. N. Dole and Dr. S. D. Sawant

ABSTRACT

The present work describes development and validation of a simple, sensitive, precise, accurate and specific UV-spectrophotometric method of analysis of Apremilast, as bulk drug and validate as per ICH guidelines. Absorbance maxima method in which λmax was found to be 230 nm. Linearity was observed in the concentration range 1-7 μg/ml (r2=0.9991) for the method. The % assay for the laboratory mixture for absorption maxima method was found to be 99.74%. Recovery studies for absorption maxima method was found to be 101.08%, 101.45% and 100.4-8% respectively. The limits of detection and quantitation were found to be 0.288 μg/ml and 0.874 μg/ml respectively. The developed method was validated for linearity, precision, accuracy, LOD and LOQ as per ICH guidelines.

Keywords: Apremilast, UV-Spectrophotometric, Absorbance maxima method, Validation and ICH guidelines.


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