LC-MS/MS method for determination of potential genotoxic impurities in imatinib mesylate

摘要

The objective of the present work was to develop LC-MS/MS method for the determination ofMethyl-3-N [4-(3-Pyridinyl)-2-pyrimidinyl]-1,3-benzenediamine(PNMP) and 4-(4-Methylpiperazinomethyl) benzoic acid dihydrochloride(MPBA) content in Imatinib Mesylate on YMC –Basic, 250 X 4.6 mm 5mm column using a gradient mixture of solvent A ( 10mM ammonium formate , adjust the pH of the above solution to 7.0 using Aq.NH3) and solvent B (Methanol(70): Acetonotrile(30)). The flow rate is 1.0ml/min. Statistical analysis proved the method to repeatable, specific and accurate for estimation of PNMP and MPBA content. It can be used as a LCMS/ MS method due to effective quantification method for trace level potential genotoxic impurities.