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.
Eserian JK, Lombardo M. Method validation in pharmaceutical analysis: from theory to practical optimization. Inov Pharm. 2015;6(1): Article 194. http://pubs.lib.umn.edu/innovations/vol6/iss1/10.