title: Performance characteristics of methods of analysis used for regulatory purposes. I. Drug dosage forms. C. Automated methods.
abstract: For analysis of drug dosage forms, precision measures of AOAC approved automated methods, usually containing a spectrophotometric or fluorometric measurement step, were recalculated on a consistent statistical basis, using a computer program "FDACHEMIST." Ten collaborative studies of 14 compounds in 38 materials, consisting of various dosage forms, usually in 10 replications by an average of 7 laboratories, with a total of 2461 determinations, were reviewed. The average relative standard deviations within-laboratory (RSDo) and among-laboratories (RSDx) were 1.1 and 1.9%, respectively, and the ratio of RSDo/RSDx was 0.57, with an average outlier rate of 0.57% of the reported values. The line of best fit for RSDx plotted against - log concentration increases slightly with decreasing concentration, extending from an RSDx of about 1.6% at 100% concentration to an RSDx of 2.2% at 0.1% concentration, a change in RSDx of about 0.2% for a 10-fold decrease in concentration, independent of analyte and matrix.
mesh_terms: D001322:Autoanalysis; D055598:Chemical Phenomena; D002621:Chemistry; D004304:Dosage Forms; D004364:Pharmaceutical Preparations / Q000032:analysis*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004304:Dosage Forms; D004364:Pharmaceutical Preparations