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Sci. Pharm. 2015, 83(4), 623-633; doi:10.3797/scipharm.1505-10

Characterization of Oxidative Degradation Product of Darunavir by LC-MS/MS

Department of Pharmaceutical Analysis, JSS College of Pharmacy, [A Constituent College of JSS University, Mysore], Udhagamandalam, Tamilnadu-643001, India
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Received: 15 May 2015 / Accepted: 30 June 2015 / Published: 30 June 2015
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Abstract

A 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.
Keywords: Characterization; Darunavir; Oxidative degradation; Validation Characterization; Darunavir; Oxidative degradation; Validation
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

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.

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