High-throughput determination of OROS® drug release rate profile using micro parallel liquid chromatography

A high throughput method with the use of micro parallel liquid chromatography (mu PLC) technique was first applied for the determination of drug release profiles in OROS (R) tablets. Currently, high-performance liquid chromatography (HPLC) is a preferred analytical tool to analyze samples released from OROS (R) tablets. However, it usually takes more than 20 h to analyze a large number of release rate samples and generate a release-rate profile. In this study, with the use of a 24-column Brio cartridge, the mu PLC enabled simultaneous analysis of 24 release-rate samples. The total analysis time including the generation of the release-rate profile was greatly reduced to 3 h. Two different OROS (R) formulations were used to compare the drug release testing using both mu PLC and conventional HPLC. The drug release profiles generated using mu PLC were comparable with those obtained by HPLC. In addition, the reproducibility and sensitivity of mu PLC analysis were examined. Overall, significant reductions in analysis time and solvent consumption were the major advantages of using mu PLC in profiling the drug release rate for a controlled-release dosage. (c) 2007 Elsevier B.V. All rights reserved.