Synthesis, Identification and Charcaterization of Potential impurities of Pomalidomide

Abstract

Pomalidomide is used for treating multiple myeloma and was synthesized for commercial use as a drug substance in highly pure form. In the process of synthesis of pure drug of pomalidomide, there is a possibility of formation of process related impurities. These impurities must be identified and controlled for producing safe medicine. In view of this, present study aimed at synthesizing four potential impurities of pomalidomide such as benzyldione, 5 – amino, desamino and nitrodion impurities. All these impurities were effectively synthesized and subsequently characterized using FT-IR, NMR and Mass spectroscopic analysis. In addition, a simple and accurate HPLC method was developed and validated for the separation and quantification of pomalidomide and its impurities synthesized in the study. The method utilizes kromasil C18 (4.6×150 mm, 5μm) column, 0.1 % orthophosphoric acid at pH 1.90±0.05 as mobile phase A, acetonitrile and mobile phase A in 60:40(v/v) as mobile phase B at 1.0 mL/min flow in gradient elution mode and UV detection at 220 nm. The method produces all validation parameters under the acceptable levels and can effectively estimate the impurities synthesized in the study. Based on the experimental findings, it can be concluded that the impurities synthesized in the developed procedure should be effectively used as reference standards for identifying and controlling the impurities in the manufacturing process of pomalidomide formulations.