Improving Method Robustness for Routine Analysis of Pharmaceutical Formulations
This technology brief explains how to improve the method robustness for the analysis of amoxicillin tablets without method revalidation.
Due to the sample complexity of formulated pharmaceutical products, manufacturers may incorporate a column wash in order to minimize carryover, and protect column performance. A high percentage organic solvent column wash, which is traditionally used, may not be the best choice in all cases. If the components of the product are insoluble in organic solvents, then a high organic wash may cause the components to precipitate out of solution, increasing pressure quickly and reducing overall method performance. Understanding the composition of the sample aids in choosing the appropriate washing step, this can improve method robustness.
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