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 (microPLC) technique was first applied for the determination of drug release profiles in OROS tablets. Currently, high-performance liquid chromatography (HPLC) is a preferred analytical tool to analyze samples released from OROS 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 microPLC 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 formulations were used to compare the drug release testing using both microPLC and conventional HPLC. The drug release profiles generated using microPLC were comparable with those obtained by HPLC. In addition, the reproducibility and sensitivity of microPLC analysis were examined. Overall, significant reductions in analysis time and solvent consumption were the major advantages of using microPLC in profiling the drug release rate for a controlled-release dosage.
Liu
Ying
Y
Analytical Development, ALZA Corporation, 1900 Charleston Road, Mountain View, CA 94039, United States. yliu16@alzus.jnj.com
Nguyen
Hoa
H
Wang
Shuang
S
Yeh
Jerry
J
D002626:Chemistry, Pharmaceutical; D002853:Chromatography, Liquid / Q000295:instrumentation* / Q000379:methods*; D003692:Delayed-Action Preparations / Q000493:pharmacokinetics*; D005240:Feasibility Studies; D009995:Osmosis; D004364:Pharmaceutical Preparations / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013607:Tablets; D013997:Time Factors
D003692:Delayed-Action Preparations; D004364:Pharmaceutical Preparations; D013607:Tablets