A NOVEL GREEN ASSESSMENT ANALYTICALMETHODTOQUANTIFY THE CONTENT OF DIMETHYLGLYOXIMEINLENALIDOMIDE USING LC-MS
TL;DR
These proposed separation strategies showed high specificity, substantiating clear resolution of DMG foreign substance by the drug compound, also with foreign substances, and confirmed the method’s suitability for both regulatory compliance and routine application in industrial Quality Control laboratories.
Abstract
A robust LC-MS method is established for the separation and quantification of Dimethylglyoxime foreign substancein Lenalidomide. Chromatographic separation was accomplished using a Zorbax Eclipse C18, 100 X4.6 mm, 3.5µcolumn. A Mixture of 0.01M of Ammonium formate as 50v/v and Acetonitrile as 50 v/v used as the mobile phase. The rate of flow is measured at 0.40mL/min with Gradient elution and mass spectrometry operating in positive ionmode. Selectivity of the method proved that protonated species of Dimethylglyoxime (m/z 117.16) separatedfromLenalidomid drug substances, with a exceptional linearity over a range of 6-120 ppm, limits of detection of 2.00ppm and quantification of 6.05 ppm. Consistent recovery rates were obtained between 90-100%, and the analytical solution remained stable for up to 72 hours at 2-8ºC. Subsequently, the developed and validated analytical methodwas assessed for environmental sustainability using established greenness assessment tools. The AGREEscore wascalculated at 0.62, and the BAGI value at 70.0. These values reflected a favorable environmental profile, efficient sample preparation, and practical sustainability. These proposed separation strategies showed high specificity, substantiating clear resolution of DMG foreign substance by the drug compound, also with foreign substances. Together, these metrics confirmed the method’s suitability for both regulatory compliance and routine applicationinindustrial Quality Control laboratories.