Jayne M. Brown, Lynn Jordan, Dale Von Behren
Caliper Life Sciences Corporation, Applications Laboratory, Hopkinton, Massachusetts, USA
Prednisone is commonly used in laboratories as a dissolution bath calibrator. Manual dissolution is a very time intensive process; hence automation of this technique is highly desirable. In this study, the MultiDose G3 Workstation is used as a tool to automate the dissolution process by heating the media, filling vessels, dropping tablets, timing the dissolution process and sampling at the appropriate intervals. In addition to reducing the hands-on time involved in dissolution, the MultiDose G3 Workstation provides a 21CFR Part 11 compliant documentation of the automated dissolution process. The objective of this study is to determine the equivalency between manual dissolution sampling and analysis and automated dissolution sampling and analysis using the Prednisone calibrator tablet.
Materials and Methods
All testing was performed using a MultiDose G3 Workstation (Caliper Life Sciences) and VK7000 dissolution bath (VanKel) with paddles and on-line MultiFill batch collection of samples in 16 x 100 test tubes. Off-line UV analysis was used to analyze the solutions with an 8453 UV/Vis Spectrophotometer (Agilent) with 1.0 cm cells.
Reagents and Standards
DI water was used for the dissolution media. The Prednisone standard Lot M was prepared according to the USP specification. The study was run using disintegrating USP Prednisone 10-mg tablets, Lot M.
The manually sampled solutions were filtered by drawing 10 mL of sample solution through a through a 35 mm VanKel Full Flow Filter. For the automated sampling, a Millipore Automation Certified 1.0 mm glass fiber filter is used.