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Characterization of Impurities Generated by Force Degradation Studies of Darunavir and Ritonavir by Lc-Ms/Ms
Author Name : Kotak Sneha Chetankumar, Dr. Vanita Marvaniya
ABSTRACT A simple, rapid, economical, precise and accurate method for characterization of impurities generated by force degradation studies of Darunavir and Ritonavir by LC-MS/MS has been developed. A Liquid chromatographyMass Spectrometry method was developed for the characterization of impurities of Darunavir and Ritonavir. The separation was achieved by LC at Horizon C18(150mm ×4.6mm ×3µm) column and ACN: Water (50:50) as mobile phase, at a flow rate of 1ml/min. Detection was carried out at 240nm. Retention time of Darunavir and Ritonavir were found to be 12.30 min and 16.14 min respectively. The drug was subjected to stress condition of Acid, Base and Oxidation degradation. Considerable Degradation was found in Base degradation. The proposed method was successfully applied for the characterization of impurities of both drugs in combination dosage form.