Development and validation of HPLC method. Review of selected cases.

Maria Puchalska ,  Łukasz Jedynak ,  Magdalena Kossykowska ,  Marta Zezula ,  Elżbieta Lipiec-Abramska ,  Marta Kościuch ,  Katarzyna E. Filip ,  Joanna Zagrodzka 

Pharmaceutical Research Institute (IF), Rydygiera 8, Warszawa 01-793, Poland

Abstract

Quality assurance of analytical results is one of the most crucial points during the development of analytical methods and their implementation to routine analytical control. The aim of validation of analytical procedure is to prove that the developed procedure fulfils the requirements concerning the assumed purpose. Validation is based on statistically documented results. Statistical tests applied during validation of analytical methods may be employed for optimization and verification of the method as early as at the stage of method development.  
HPLC is one of the most often used analytical techniques during development and production of drug substances. Range of application, accuracy, precision and linearity of chromatographic method are dependent on several factors such as interactions between chromatographed analyte and both mobile and stationary phase, absorption of UV-VIS radiation (if spectrophotometric detection is used) or stability of the sample.
Application of statistical tools during the development of chromatographic methods applied for determination of chemical purity and assay of drug substances is presented using a few chosen examples. Use of the statistical tests for determination of such parameters as linearity, range, accuracy, precision and limit of quantification is also demonstrated.

 

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Presentation: Oral at VIII Multidyscyplinarna Konferencja Nauki o Leku, by Maria Puchalska
See On-line Journal of VIII Multidyscyplinarna Konferencja Nauki o Leku

Submitted: 2012-03-24 11:44
Revised:   2012-04-11 12:07