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Validation of a LC method for the analysis of oxaliplatin in a pharmaceutical formulation using an experimental
R Ficarra1, M L Calabrò, P Cutroneo
1Dipartimento di Scienze Farmaco-Biologiche, Università di Catanzaro Magna Graecia, Complesso Ninì Barbieri, 88021 Roccelletta di Borgia, Catanzaro, Italy. pficarra@pharma.unime.it
Abstract:
A rapid and sensitive RP-HPLC method with UV detection for routine control of oxaliplatin in a pharmaceutical formulation (Eloxatin) was developed. Quantitation was accomplished with the internal standard method. The procedure was validated by linearity (correlation coefficient=0.999948), accuracy, robustness and intermediate precision. Experimental design was used during validation to calculate method robustness and intermediate precision. For robustness test three factors were considered: percentage v/v of acetonitrile, flow rate and temperature; an increase in the flow rate results in a decrease of the drug found concentration, while the percentage of organic modifier and temperature have no important effect on the response. For intermediate precision measure the considered variables were: analyst, equipment and days. The RSD value (2.27%, n=24) indicated a good precision of the analytical method.