Abstract

COMPREHENSIVE COMPILATION OF ANALYTICAL METHODOLOGIES FOR ESTIMATION OF APREMILAST

Harshal Marathe* and Varsha Patil

ABSTRACT

Apremilast belongs to the class of phosphodiesterase 4 (PDE4) inhibitors having potential anti-inflammatory activity. Apremilast is used in the treatment of psoriasis and psoriatic arthritis. It belongs to the class of isoindoles that is isoindole-1,3-dione substituted at position 4 by an acetamido group and position 1 by a 1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl) ethyl group. The current review is mainly based on the analytical, bioanalytical method development approaches and various methods developed for the drug apremilast either in pharmaceutical dosage form or in bulk. Analytical techniques are very much important for the determination of the compositions by using the advanced analytical instruments by which we can get both qualitative as well as quantitative results. These methods aid in the understanding of important process parameters and the reduction of their effect on precision and accuracy. The need for analytical method development is to maintain quality standards of high commercial products and to fulfill the regulatory requirements. Regulatory bodies of different countries have set the standards and procedures for granting approval, authentication, and registration following the reference. The presented paper is a compilation of numerous dosage forms and analytical methodologies reported for qualitative as well as quantitative analysis of APL.

Keywords: Apremilast, analytical techniques, HPLC, UV, bioanalytical techniques, Psoriasis, Psoriatic Arthritis.