Evaluation of a liquid chromatographic method for analysis of Indinavir and degradation products arising from hydrolysis of its amide bond

Abstract

Indinavir, an antiviral drug, is a member of the novel hydroxyaminopentane amides class of HIV-1 protease inhibitors. It is the active substance in capsules which contain 400 mg indinavir as the sulfate salt and degradation products, a lactone and cis-aminoindanol, arising as a result of hydrolysis of its amide bond (at most 1.5% of the lactone and 0.5% cis-aminoindanol). RP HPLC has been evaluated as a method for qualitative and a quantitative analysis of indinavir and its degradation products in capsules. During method development the effects of several stationary and mobile phases on the separation were investigated. Separations were performed on an X Terra RP18, 150 mm x 4.6 mm, 5 mu m particle size, column at 20 degrees C. The mobile phase was 35:65 (v/v) mixture of acetonitrile and an aqueous solution of sodium lauryl sulfate and triethylamine. UV detection was performed at 214 nm. Important statistical data were determined for validation of the selectivity/specificity, linearity, precision, robustness, limit of detection, and limit of quantitation of the method. The validated method was then used for determination of amounts of indinavir (recovery between 100.6 and, 103.1%) and compounds resulting from hydrolysis of its amide bond (the lactone, 0.265%, and cis-aminoindanol, 0.07%). The method is suitable for simultaneous determination of indinavir and its degradation products in pharmaceuticals and the bulk drug.