II–V. While these Tables do not exhaustively capture the entiredatabase of pharmaceutical applications of IC, they do providerelevant examples of the types of separation/detection strategiesthat are used in this field.Method ValidationAs IC is a liquid chromatographic method, guidelines for thevalidation of IC applications in the pharmaceutical industry arereadily available (6–8) and most of the applications cited in thismanuscript contain some degree of assay validation information.Comprehensive validation information, specifically with respectto the common validation parameters (e.g., accuracy, linearity,precision, specificity, sensitivity, and ruggedness), is summarizedin Table VI for the various pharmaceutical applications ofIC. Consistent with the nature of the application (trace analysisversus content/potency), the operating characteristics are similarto those that are routinely obtainable in more classical applicationsof liquid chromatography (e.g., HPLC).IC is extensively employed in the environmental and foodindustries. As the requirements for quality in these disciplinesare similar to those in the pharmaceutical industry, applicationsin these fields have been extensively validated, including the utilizationof inter-laboratory collaborative assessments (9–16,99–102).
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