Validation of a LC method for the analysis of oxaliplatin in a pharmaceutical formulation using an experimental design

A rapid and sensitive RP-HPLC method with UV detection for routine control of oxaliplatin in a pharmaceutical formulation (Eloxatin(R)) 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 temperatures 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. (C) 2002 Elsevier Science B.V. All rights reserved.