Abstract

TRIGO ORSINI, Myriam Lina  and  PARRA POMA, Cinthia Maribel. Validation of the method for the quantification of cyclosporine a in whole blood by HPLC / DAD. Rev.Cs.Farm. y Bioq [online]. 2019, vol.7, n.1, pp.67-80. ISSN 2310-0265.

Abstract This study describe the validation method for the quantification of Cyclosporin A in Whole Blood by Liquid Chromatography High Efficiency (HPLC) in reverse phase. Cyclosporine A is immunosuppressant United Nations UN the narrow scam therapeutic margin: In addition to its extensive ¿variability in pharmacokinetic processes justify their monitoring dose Patients with organ transplants paragraph Avoid Side Effects and poaible organ rejection transplanted. Separation of Cyclosporine A of a matrix complex as the blood was carried out successfully using as the stationary phase C8 column, the mobile phase is a mixture of acetonitrile and water gradient, flow 1.4 ml / min, Temperature column was 75 ° C detection 210 nm in one. The method was validated with the following parameters: specificity, linearity, precision, accuracy, limit of detection and limit of quantification. Aptitude Test System was also performed. Was Method Specific for Cyclosporin A, the response was linear in the range 100 a 1000 ng/mL concentration of the analyte. The coefficient of variation or relative standard deviation (RSD or CV) for the precision was optimal. Recovery media WAS 103,06%. And the limit of detection and quantification were optimal for the quantification of total Cyclosporine in blood in the range defined. Finally Chromatographic Method allowed us to separate and quantify Cyclosporin A in samples of patients with renal transplantation.

Keywords : Cyclosporine A; bioavailability; pharmacokinetics; renal transplantation; high-performance liquid chromatography.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )