Improving method capability of a drug substance HPLC assay

Journal of Pharmaceutical and Biomedical Analysis
B DejaegherY Vander Heyden

Abstract

The assay of a drug substance (DS) is one of the tests required to confirm the active pharmaceutical ingredient (API) quality at release. In the past, usually volumetric titration methods were performed, that were precise, but often non-specific. Nowadays specific chromatographic assay procedures are preferred. However, high performance liquid chromatographic (HPLC) methods, the way they are usually executed, tend to be less precise and have a larger total method variation compared to titration methods. The capabilities of fully validated titration and HPLC assay methods were determined and compared. It was studied which factors had the largest effects on the capability of chromatographic HPLC methods in order to improve their precision and precision-to-tolerance ratio. This was done using multiple Gage R&R (repeatability & reproducibility) studies and an experimental design approach. The investigations showed that it was feasible to define an HPLC method with a similar capability as the titration method. The most important factor determining the precision was demonstrated to be higher sample and reference material weights. When low weights are to be used, increasing the number of sample preparations and the number of reference...Continue Reading

References

Sep 21, 2000·Journal of Chromatography. B, Biomedical Sciences and Applications·B Renger
Feb 24, 2001·Journal of Pharmaceutical and Biomedical Analysis·S HouP R Byron
Oct 21, 2003·Journal of Pharmaceutical and Biomedical Analysis·Kaustubh R TambwekarSanjay Garg
Dec 6, 2003·Journal of Pharmaceutical and Biomedical Analysis·Mehmet Aslanoglu, Nesrin Peker
Sep 1, 2004·Journal of Pharmaceutical and Biomedical Analysis·Meiling QiJianjun Yang
Sep 8, 2004·Journal of Pharmaceutical and Biomedical Analysis·Petra KovaríkováLucie Tisovská
Dec 29, 2004·Journal of Pharmaceutical and Biomedical Analysis·Sándor Görög
Jun 9, 2005·Journal of Chromatography. a·E Van GyseghemaY Vander Heyden

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Citations

Oct 26, 2010·Journal of Pharmaceutical and Biomedical Analysis·M T OldenhofD M Barends
Jul 31, 2009·Journal of Pharmaceutical and Biomedical Analysis·J F van LeeuwenD M Barends
Jul 15, 2009·Journal of Pharmaceutical and Biomedical Analysis·Peter J SkrdlaJean Wyvratt
Dec 4, 2010·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Marika KamberiRichard J Rapoza
Dec 18, 2007·Journal of Pharmaceutical and Biomedical Analysis·Sándor Görög
Jan 17, 2012·Analytica Chimica Acta·A BouabidiE Rozet
Nov 24, 2011·Analytical Chemistry·E RozetPh Hubert

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