A controlled study was conducted to evaluate the feaslblllty of robotlc automatlon of routlne regulatory drug dlssolutlon measurements. A commercially available laboratory robot system automated a number of dlssolutlon analyses while concurrent manually acquired samples were analyzed by the same analytlcal method. Five welltharacterlzed drug tablet types were employed, lncludlng the two current "Unlted States Pharmacopeia" (USP) Method I I calibrators, These tablet types spanned a range of dlslntegratlon and dlssolutlon rates. I n all, over 150 tablets were analyzed. The results were subjected to a statlstlcal analysls of varlance ( ANOVA).ARer some small sources of systematic blas were eliminated, the results obtained by the robot were statlstlcally lndistlngulshable from the manual results. Addltlonally, the overall ranges of total drug dissolved were comparable to those obtalned from a dlssolutlon Interlaboratory collaborative study and to range llmlts for the USP calibrator tablets.
General users of computer software and hardware, like general users of analytical instrumentation, must be confident that the results are accurate. As with instrumentation, a rigorous quality assurance program can be implemented and the results compared with well-known, expected values. With software, however, one must also look at the results obtained with erroneous and out-of-range data or conditions. Thus, the overall system should be rigorously exercised through all possible data combinations.
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