INNOVATIONS in pharmacy

Method validation in pharmaceutical analysis: from theory to practical optimization

Jaqueline Kaleian Eserian

Márcia Lombardo

DOI: https://doi.org/10.24926/iip.v6i1.376

Keywords: validation studies, chromatography

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Abstract

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