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Development and validation of a

HPLC method for the determination

of cyclosporine a in new bioadhesive

nanoparticles for oral Administration

M Pecchio, H Salman, JM Irache, MJ Renedo, MC Dios-Viéitez.

Abstract

A simple and reliable high performance liquid chromatography method was developed and validated for the rapid determination of cyclosporine A in new pharmaceutical dosage forms based on the use of poly (methylvinylether-co-maleic anhydride) nanoparticles. The chromatographic separation was achieved using Ultrabase C 18 column (250×4.6 mm, 5 μm), which was kept at 75°. The gradient mobile phase consisted of acetonitrile and water with a flow rate of 1 ml/min. The effluent was monitored at 205 nm using diode array detector. The method exhibited linearity over the assayed concentration range (22-250 μg/ml) and demonstrated good intraday and interday precision and accuracy (relative standard deviations were less than 6.5% and the deviation from theoretical values is below 5.5%). The detection limit was 1.36 μg/ml. This method was also applied for quantitative analysis of cyclosporine A released from poly (methylvinylether-co-maleic anhydride) nanoparticles.

M Pecchio, H Salman, JM Irache, MJ Renedo, MC Dios-Viéitez, Indian Journal of Pharmaceutical Sciences, 2014 in press.