Research Journal of Pharmacy and Technology
SCOPUS
  • Year: 2018
  • Volume: 11
  • Issue: 8

Study of Forced Degradation behavior of Atazanavir

Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy GITAM (Deemed to be University), Visakhapatnam-530045, India

*Corresponding Author E-mail: naren_angirekula@yahoo.com

Online published on 31 October, 2018.

Abstract

A modified simple and sensitive stability indicating RP-HPLC method has been developedfor the determinationof Atazanavir in presence of its degradant products on isocratic mode. The method was validated and forced degradation studies were performed as per ICH guidelines. Hypersil ODS C-18 Column (250mmx4.6 mm, i.d.5μ particle size) using methanol:tetra butyl ammonium hydrogen sulphatemixture with flow rate 1.0 ml/min are the chromatographic conditions for the present study (UV detection 247 nm) (Isocratic mode). Atazanavir was eluted at 4.86 min within the total run time of 10 min. Atazanavir shows linearity 0.5–200 μg/mL (r2 = 0.999). The method was validated and found to be specific as the degradants were not at allinterferingwith Atazanavir.

Keywords

Atazanavir, Stabilityindicating, HPLC, ICH Guidelines