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Portable and automated analyzer for rapid and high precision in vitro dissolution of drugs

Journal of Pharmaceutical Analysis 2021年第4期11卷 490-498页

作者： Zhongmei Chi Siqi Zhao Xiujun Cui Yunxiang Feng Li Yang Key Laboratory of Nanobiosensing and Nanobioanalysis at Universities of Jilin Province Department of ChemistryNortheast Normal UniversityChangchun130024China Jingke-Oude Science and Education Instruments Co. LtdChangchun130024China

We developed a novel portable and automated dissolution test analyzer for rapid and high precision in vitro dissolution testing of *** analyzer consists of a flow-through-cell drug dissolution system,an automated sequential sampling system,a high-speed capillary electrophoresis(HSCE)system,and a data acquisition *** the high-temporal resolution flow-gating sampling approach with HSCE,which has outstanding advantages of efficient separation and resolution,the analyzer can achieve rapid analysis and exhibits the ability in miniaturization for on-site assessment of different active pharmaceutical *** integrate the flow-through-cell dissolution system with HSCE,a specially designed flow-gating-injection(FGI)interface was *** performance of the analyzer was investigated by analyzing the dissolution of immediate-release drugs including single dose(amoxicillin dispersible tablets)and fixed dose combination(amoxicillin and clavulanate potassium)drug tablets with the high-temporal resolutions of 12 s and 20 s,*** dissolution profiles of different active pharmaceutical ingredients could be simultaneously and automatically monitored with high repeatability and *** analyzer was successfully utilized for the pharmaceutical quality control and bio-relevant dissolution testing,as well as in vivo-in vitro correlation *** portable analyzer is miniaturized,convenient and of low-cost,and will provide a valuable tool for dissolution testing in pharmaceutical research and development.

关键词： dissolution test analyzer Portable Automated Immediate-release drug Fixed dose combination drug

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