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Abstract

Development and validation of a HPLC method for the determination of cyclosporine a in new bioadhesive nanoparticles for oral Administration

Author(s): M Pecchio1, H Salman2, JM Irache3, MJ Renedo3, MC Dios-Vieitez3
1Instituto de Investigaciones Cientificas y Servicios de Alta Tecnologia, Republic of Panama 2Bionanoplus Company Pol, Mocholi, Plaza Cein 5, Noain, Spain 3Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Navarra, Spain

Correspondence Address:
MC Dios-Vieitez Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Navarra Spain E-mail: [email protected]


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.

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