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Development and Validation of a HPLC Method for the Determination of Cyclosporine A in New Bioadhesive Nanoparticles for Oral Administration |
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| Authors: | M Pecchio H Salman J M Irache M J Renedo M C Dios-Viéitez |
| Institution: | Instituto de Investigaciones Científicas y Servicios de Alta Tecnología (INDICASAT AIP), Ciudad del Saber, Clayton, Edif. 219, PO. Box 0843-01103, Panamá 5, Panamá, Republic of Panamá;1.Bionanoplus Company Pol, Mocholí, Plaza Cein 5, nave B14, 31110-Noáin, Spain;2.Department of Pharmacy and Pharmaceutical Technology, Faculty of Pharmacy, University of Navarra, Irunlarrea, 1. 31008-Pamplona, Spain |
| 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 C18 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. |
| Keywords: | Cyclosporine A HPLC-UV nanoparticles poly (methylvinylether-co-maleic anhydride) oral administration |