Method validation in pharmaceutical analysis: from theory to practical optimization

  • Jaqueline Kaleian Eserian
  • Márcia Lombardo
Keywords: validation studies, chromatography


The validation of analytical methods is required to obtain high-quality data. For the pharmaceutical industry, method validation is crucial to ensure the product quality as regards both therapeutic efficacy and patient safety. The most critical step in validating a method is to establish a protocol containing well-defined procedures and criteria. A well planned and organized protocol, such as the one proposed in this paper, results in a rapid and concise method validation procedure for quantitative high performance liquid chromatography (HPLC) analysis.


Type: Commentary


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Received 2016-02-10
Published 2015-01-01