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Validation of a computerized image analysis system for particle size determination Pharmaceutical applications

1992; Elsevier BV; Volume: 88; Issue: 1-3 Linguagem: Inglês

10.1016/0378-5173(92)90328-y

1873-3476

Joel P. Zingerman, Surendra C. Mehta, Jeremy M. Salter, Galen W. Radebaugh,

Drug Solubulity and Delivery Systems

This study describes the methods used to validate the sample preparation procedure, measurement parameters, and statistical capabilities of an Olympus Cue-2 image analysis (IA) system. The sample preparation of a micronized pharmaceutical compound for optical microscopy/IA was validated by scanning electron microscopy. The effect of microscope and IA system configuration on measurement accuracy was demonstrated using National Bureau of Standards traceable particle-size standards. Magnification alone can induce a 20% error in the reported mean particle size of 10 μm diameter standard microspheres. By selecting the optimum microscope configuration, this source of error can be avoided. Aspect ratio (length to width ratio) measurements varied in accuracy from 4 to 450% depending on the true particle shape and orientation in the field of view. Algorithms employing Feret's diameter and are provided more accurate aspect ratio values. The IA system's statistical capabilities were validated by comparison to IA raw data reduction using Lotus 123®. To meet regulatory guidelines, it is imperative that the entire system and analysis method be validated prior to routine use.