Chromatographia

, Volume 63, Issue 9–10, pp 437–443 | Cite as

LC Method for Studies on the Stability of Lopinavir and Ritonavir in Soft Gelatin Capsules

  • E. M. Donato
  • C. L. Dias
  • R. C. Rossi
  • R. S. Valente
  • P. E. Fröehlich
  • A. M. Bergold
Article

Abstract

This study describes the development and full validation of a stability-indicating HPLC method to quantify ritonavir (RTV) and lopinavir (LPV) in soft gelatin capsules. The method uses a LiChrospher® 100 RP-18 (250 mm × 4.6 mm, 5 µm, Merck) column and isocratic elution. The mobile phase consisted of a mixture of acetonitrile-water-methanol (53:37:10, v/v/v), pumped at a flow-rate of 1.0 mL min−1 and UV detection at 210 nm using a photodiode array detector. LPV and RTV were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. The response was linear over a range of 40-360 µg mL−1 for LPV and 10–90 µg mL−1 for RTV (r > 0,999 for both drugs). The mean recoveries were 99.46 and 100.81% for LPV and RTV, respectively. The RSD values for intra- and inter-day precision studies were < 0.70% for both drugs. Degradation studies showed that lopinavir is stable in thermal, alkaline and oxidative conditions, while ritonavir degraded under these conditions. The method was found to be stability-indicating and can be used for the routine analysis of the association LPV/RTV in soft gelatin capsules.

Keywords

Column liquid chromatography Stability-indicating method Validation Lopinavir/ritonavir protease inhibitors 

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Copyright information

© Friedr. Vieweg & Sohn/GWV Fachverlage GmbH 2006

Authors and Affiliations

  • E. M. Donato
    • 1
  • C. L. Dias
    • 1
  • R. C. Rossi
    • 1
  • R. S. Valente
    • 1
  • P. E. Fröehlich
    • 1
  • A. M. Bergold
    • 1
  1. 1.Programa de Pós-Graduação em Ciências Farmacêuticas, Faculdade de FarmáciaUniversidade Federal do Rio Grande do Sul – UFRGSPorto Alegre CEPBrasil

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