Low level quantification of two potential genotoxic impurities in rilpivirine hydrochloride drug substance by HPLC technique
Keywords:
Rilpivirine hydrochloride, 4-Iodo-2,6 Dimethyl aniline, 3-Iodo-2,6 Dimethyl aniline, potential genotoxic impurities, analytical method validationAbstract
The goal of the research work was to develop new specific analytical method for the determination of potential genotoxic impurities 4-Iodo-2,6 Dimethyl aniline and 3-Iodo-2,6 Dimethyl aniline in Rilpivirine hydrochloride drug substances. The method was developed by using reverse phase high performance liquid chromatography technique. The comprehensive method development was done to accomplish right combination of chromatographic conditions and validated as per ICH guidelines. The method utilizes L1-octadecyl chemistry (250 millimeter (mm) x 4.6 mm ID, 5.0 micrometer (μm), HPLC column. Both impurities were detected by ultra violet detector at 210nm. The separation of both impurities was attained with 0.1% Ortho Phosphoric Acid in water and acetonitrile at 1.2 ml/min. The calibration curve exhibited good linearity over the concentration range of 0.12-0.45 μg/ml with coefficient of correlation value greater than 0.999. The accuracy in terms of % recovery of the added known amount was found in the range of 97-100 %. Based on experimental results, developed analytical method can be applied for the low level quantitation of both potential genotoxic impurities in Rilpivirine hydrochloride.
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