Summary
One possible method has been demonstrated for pharmaceutical quality control which is not restricted to this field and fulfils and documents the prerequisites for reliable, accurate and precise HPLC analysis. This includes validation which shows that the method is able in principle to fulfil the requirements, the apparatus test which shows that the apparatus generally works correctly and precisely and the system suitability test which shows that the method provides accurate and precise results on this apparatus and with this column for the analysis in question when other non-equipment and non-method-induced errors are excluded.
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References
Current Concepts for the Validation of Compendial Assays. Pharmacopeial Forum (1986), 1241–1245.
Unpublished Internal Memo, F. Walter, Bayer AG, Leverkusen.
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Maldener, G. Requirements and tests for HPLC apparatus and methods in pharmaceutical quality control. Chromatographia 28, 85–88 (1989). https://doi.org/10.1007/BF02290388
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DOI: https://doi.org/10.1007/BF02290388