Open AccessDetermination of Possible Potential Genotoxic Impurities in Lenalidomide Drug Substance by Simple RP-HPLC Method
Author(s) -
Kishore Gaddam,
Karuna Shanker,
Trivikram Reddy Gundala,
Yogeshwar Reddy Mamilla,
N. C. Gangi Reddy
Publication year - 2020
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2020.22856
Subject(s) - chemistry , chromatography , high performance liquid chromatography , acetonitrile , solvent , impurity , methanol , perchloric acid , detection limit , organic chemistry
This study is concerned with development and validation of HPLC method for the simultaneousdetection and quantification of methyl 2-(chloromethyl)-3-nitrobenzoate (MCN), methyl2-(bromomethyl)-5-nitrobenzoate (MMM), methyl 2-(bromomethyl)-6-nitrobenzoate (MON), methyl2-(bromomethyl)-4-nitrobenzoate (MPN) and 2-methyl-3-nitrobenzoic acid methyl ester (MNM), whichare the genotoxic impurities of lenalidomide. Chromatographic separation was accomplished using aWaters HPLC system equipped with Ascentis Express F5 (150 × 4.6 mm, 2.7 μm) using mobile phasecomposed of solvent A (0.1% perchloric acid): solvent B (methanol 80% and acetonitrile 20%); 55:45,vol/vol. The selected impurities were detected using UV detector set at 210 nm. The standard curvesshowed linearity in the range of concentrations 4.59-91.2 ppm (for MCN), 6.58-90.0 ppm (for MMM),3.96-89.1 ppm (for MON), 6.47-89.7 ppm (for MPN) and 4.28-90.1 ppm (for MNM). The statisticalresults of method precision, system precision, specificity, accuracy, ruggedness was found to be withinlimits of acceptance. All the impurities were stable in lenalidomide test samples up to 24 h.