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. 2014 Mar;76(2):132-7.

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

M Pecchio  1 , H Salman  2 , J M Irache  3 , M J Renedo  3 , M C Dios-Viéitez  3
Affiliations

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

M Pecchio et al. Indian J Pharm Sci. 2014 Mar.

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; oral administration; poly (methylvinylether-co-maleic anhydride).

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Figures

Fig. 1
Fig. 1
Chemical structure of CYA. CYA is cyclosporine A.
Fig. 2
Fig. 2
Chemical structure of PVM/MA. PVM/MA is poly(methylvinylether-co-maleic anhydride).
Fig. 3
Fig. 3
Chromatograms of drug, blank and drug-loaded nanoparticles. Chromatograms obtained after processing a drug-free PVM/MA solution (a), a calibration standard containing 250 mg/ml of CYA (b) and PVM/MA nanoparticles loading CYA (c). tR is retention time, PVM/MA is poly(methylvinylether-co-maleic anhydride) with tR of 4.7 min, CYA is cyclosporine A with tR of 6.5 min.
Fig. 4
Fig. 4
CYA release profile from PVM/MA nanoparticles in SGF and SIF. CYA release profile from PVM/MA nanoparticles after incubation in simulated gastric and intestinal fluids at 37°. Data represented as mean±SD (n=3). CYA=cyclosporine A, PVM/MA=poly(methylvinylether-co-maleic anhydride), SGF=simulated gastric fluid, SIF=simulated intestinal fluid, SD=standard deviation for n=3 observations.
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