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

J Pharm Biomed Anal. 2002 Aug 1;29(6):1097-103. doi: 10.1016/s0731-7085(02)00151-6.

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.

Publication types

  • Validation Study

MeSH terms

  • Antineoplastic Agents / analysis*
  • Chromatography, High Pressure Liquid / methods*
  • Linear Models
  • Organoplatinum Compounds / analysis*
  • Oxaliplatin
  • Pharmaceutical Preparations / chemistry
  • Reproducibility of Results
  • Spectrophotometry, Ultraviolet

Substances

  • Antineoplastic Agents
  • Organoplatinum Compounds
  • Pharmaceutical Preparations
  • Oxaliplatin