Micellar electrokinetic chromatography method development for determination of impurities in ritonavir.
Ritonavir is a synthetic peptidomimetic human immunodeficiency virus (HIV) protease inhibitor employed in the treatment of AIDS since 1996. Synthetic precursors are potential impurities in the final product. In the present work a micellar electrokinetic chromatography (MEKC) method for the separation of Ritonavir from three available synthetic precursors was developed. The optimized separation is performed in a background electrolyte composed of sodium tetraborate (pH 9.6; 15mM) containing sodium dodecylsulfate (30mM) and acetonitrile (18%, v/v). Mass spectrometry was used to confirm the identity of the tested substances. Good repeatability was observed for migration time (RSD about 0.4%) and peak area (RSD about 0.8%). The limits of detection (LOD) obtained allow the determination of two of the impurities at levels as low as 0.005% m/m, and one at a level of 0.3% m/m.
Carvalho
Alexandre Zatkovskis
AZ
Laboratory for Pharmaceutical Analysis, Faculteit Farmaceutische Wetenschappen, Katholieke Universiteit Leuven, O & N 2, PB 923, Herestraat 49, B-3000 Leuven, Belgium.
El-Attug
Mohamed Nouri
MN
Zayed
Sahar Ebrahem
SE
Hove
Els Van
EV
Duppen
Joost Van
JV
Hoogmartens
Jos
J
Schepdael
Ann Van
AV
D020374:Chromatography, Micellar Electrokinetic Capillary / Q000379:methods* / Q000592:standards; D004340:Drug Contamination; D017320:HIV Protease Inhibitors / Q000032:analysis / Q000737:chemistry; D008823:Micelles; D019438:Ritonavir / Q000032:analysis* / Q000737:chemistry
D017320:HIV Protease Inhibitors; D008823:Micelles; D019438:Ritonavir