A sensitive and selective HPLC method was developed for identification and quantification of five Potential genotoxic impurities (PGIs) viz. Impurity-I, Impurity-II, Impurity-III, Impurity-IV and Impurity-V in Dalfampridine (Drug substance). The method utilizes Zorbax silica column (250mm×4.6mm, 5.0μm) with UV detector in HILIC (Hydrophilic Interaction Liquid Chromatography) mode for quantitation of five PGIs. It has been validated as per International Council for Harmonisation (ICH) guidelines and is able to quantitate all PGIs at 75ppm with respect to 20mg/mL of sample concentration. It is linear in the range of 22.5-112.5ppm for all PGIs, which matches the range of LOQ-150% of estimated permitted level (75ppm). Its accuracy was established in the range from 88.14 to 107.65% for these PGIs. The correlation coefficient of each impurity was >0.999. It is a good quality control tool for quantitation of PGIs in Dalfampridine at low level.
Keywords: Dalfampridine; Genotoxic impurity; HILIC mode; RP-HPLC; UV detector; Validation.
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