Increased Throughput and Sensitivity Obtained with 1.0 mm i.d. Columns Packed with 1.7 µm Particles for High Resolution, Ultra Fast Stability-Indicating Method Development

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Eric S. Grumbach, Thomas E. Wheat, Jeffrey R. Mazzeo and Diane M. Diehl Waters Corporation
2004 AAPS Annual Meeting and Exposition, November 7-11, Baltimore MD
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Terbinafine, Antifungal
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Forced Degradation

Pharmaceutical scientists must develop assay procedures that completely identify and measure all degradation products of an active pharmaceutical ingredient. Due to its ability to separate degradation products, excipients and process impurities from active ingredients, HPLC has become the analytical tool of choice for stability-indicating assays. However, there is always the requirement to achieve better resolution to ensure complete characterization of the degradants. At the same time, improvements in sensitivity to detect trace level components and improved sample throughput need to be addressed. These assays can benefit from utilizing sub-2 µm particulate columns to improve resolution for critical pairs or maintain existing resolution while improving sample throughput. In this study, we examine this approach, applying UltraPerformance LC UPLC to the degradants of the antifungal terbinafine.


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