LIQUID CHROMATOGRAPHY MASS SPECTROMETRIC METHOD FOR QUANTIFICATION OF POTENTIAL GENOTOXIC IMPURITY 2, 6-DIAMINOPYRIDINE IN MINODRONIC ACID

A new, simple, accurate and sensitive method was developed for the quantification of potential genotoxic impurity 2, 6-Diaminopyridine in Minodronic acid using Liquid Chromatographic Mass Spectrometry (LCMS). The chromatographic separation was achieved on ZIC HILIC, 5u (150 x 4.6) mm column with isocratic programme and elution was monitored by mass spectrometer in Single Ion Monitoring mode using electrospray ionization. The LOD and LOQ values were found to be 1.0 ppm and 3.0 ppm respectively for the impurity at the test concentration of 0.5mg/ml. The method was linear (r2>0.99), precise (RSD<2%), accurate and well within acceptable ICH limits.