Capillary electrophoretic method for determination of protease inhibitor indinavir sulfate used in human immunodeficiency virus therapy

• Published in: Journal of pharmaceutical and biomedical analysis 2004-02, Vol.34 (2), p.441-450
• Main Authors: Aurora Prado, Marı́a S, Kedor-Hackmann, Erika R.M, Santoro, Maria Inês R.M, Pinto, Terezinha J.A, Tavares, Marina F.M
• Format: Article
• Language: English
• Subjects: Analysis; Analytical, structural and metabolic biochemistry; Biological and medical sciences; Capillary electrophoresis; Chemistry, Pharmaceutical; Electrophoresis, Capillary - methods; Fundamental and applied biological sciences. Psychology; General pharmacology; HIV; HIV Infections - drug therapy; HIV Protease Inhibitors - analysis; HIV Protease Inhibitors - chemistry; HIV Protease Inhibitors - therapeutic use; Human immunodeficiency virus; Indinavir - analysis; Indinavir - chemistry; Indinavir - therapeutic use; Indinavir sulfate; Medical sciences; Pharmacology. Drug treatments; Protease inhibitor
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/S0731-7085(03)00530-2

A simple, fast and reliable capillary electrophoresis (CE) method for determination of indinavir sulfate, a potent protease inhibitor used in human immunodeficiency virus (HIV) therapy, in commercial and simulated capsule formulations is described. The analysis was performed in a 75 μm i.d. uncoated fused-silica capillary with 27 cm length (effective length of 19.4 cm) using a 20 mmol l −1 phosphate buffer at pH 2.52. Samples were injected hydrodynamically by applying 0.5 psi pressure during 2 s. The applied voltage was 28 kV. Direct UV detection at 214 nm led to an adequate sensitivity without interference from sample excipients and known impurities. For quantitative purposes, diazepam was used as internal standard. Under optimized conditions, the migration times for indinavir sulfate and diazepam were 1.06 and 1.66 min, respectively. Analytical curve of peak area ratios versus concentration in the range of 20.0–100.0 μg/ml gave a coefficient of correlation of 0.9992, establishing the method linearity. The limits of detection and quantitation were 4.61 and 14.0 μg/ml, respectively. The within-day precision expressed as relative standard deviation was