Characterization of Oxidative Degradation Product of Darunavir by LC-MS/MS
AbstractA rapid, selective, and reliable LC-MSn method has been developed and validated for the isolation and structural characterization of the degradation product of darunavir (DRV). DRV, an HIV-1 protease inhibitor, was subjected to intrinsic oxidative stress conditions using 30% hydrogen peroxide and the degradation profile was studied. The oxidative degradation of DRV resulted in one degradation product. The unknown degradation product was separated on a Hibar Purospher C18 (250 mm × 4.6 mm; 5 µm) column by using 0.01 M ammonium formate (pH 3.0) and acetonitrile as mobile phase in the ratio of 50:50, v/v. The eluents were monitored at 263 nm using a UV detector. The isolated degradation product was characterized by UPLC-Q-TOF and its fragmentation pathway was proposed. The proposed structure of the degradation product was confirmed by HRMS analysis. The developed stability-indicating LC method was validated with respect to accuracy, precision, specificity/selectivity, and linearity. No prior reports were found in the literature about the oxidative degradation behavior of DRV.
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YAMJALA, K.; ATUKURI, J.; NAGAPPAN, K.; SHIVARAJU, N.H.; NAINAR, M.S. Characterization of Oxidative Degradation Product of Darunavir by LC-MS/MS. Sci. Pharm. 2015, 83, 623-633.
YAMJALA K, ATUKURI J, NAGAPPAN K, SHIVARAJU NH, NAINAR MS. Characterization of Oxidative Degradation Product of Darunavir by LC-MS/MS. Scientia Pharmaceutica. 2015; 83(4):623-633.Chicago/Turabian Style
YAMJALA, Karthik; ATUKURI, Jeevitha; NAGAPPAN, Krishnaveni; SHIVARAJU, Nivedeetha H.; NAINAR, Meyyanathan S. 2015. "Characterization of Oxidative Degradation Product of Darunavir by LC-MS/MS." Sci. Pharm. 83, no. 4: 623-633.