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

作者：Pecchio M; Salman H; Irache J M; Renedo M J; Dios Vieitez M C^*

来源：Indian Journal of Pharmaceutical Sciences, 2014, 76(2): 132-137.

• Cyclosporine A
• HPLC-UV
• nanoparticles
• poly (methylvinylether-co-maleic anhydride)
• oral administration

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 (250x4.6 mm, 5 m), which was kept at 75 degrees. 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 g/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 g/ml. This method was also applied for quantitative analysis of cyclosporine A released from poly (methylvinylether-co-maleic anhydride) nanoparticles.

• 出版日期2014-4