Development and validation of a capillary electrophoresis method for the determination of sulfate in indinavir sulfate raw material

Abstract

In this work, a simple and fast capillary electrophoresis method using indirect UV detection (230 nm) for the quantitative determination of sulfate in the indinavir sulfate raw material was described. A running electrolyte consisting of 10 mmol L-1 ammonium molybdate containing 0.15 mmol L-1 cetyltrimethylammonium bromide (pH 7.5) was used. Samples were injected hydrodynamically by applying 5000 Pa pressure during 3 s. The response was linear from 10.1 µg mL-1 to 79.8 mg µL-1. Limits of detection and quantification were 0.34 and 1.13 mg µL-1, respectively. The intra-day precision expressed as relative standard deviation was 2.8% for 10 independent sample preparations. Recoveries varying from 96.9 to 102.4% at three concentration levels were obtained. The methodology was successfully applied for real samples. The concentration of sulfate in indinavir sulfate raw material varied from 13.3 to 13.5% (m/m calculated as anhydrous base).

Keywords

• indinavir sulfate
• capillary electrophoresis
• sulfate
• validation
• HIV