Abstract
Dissolution testing plays many important roles throughout the pharmaceutical industry, from the research and development of drug products to the control and evaluation of drug quality. However, it is a challenging task to perform both high-efficient separation and high-temporal detection to achieve accurate dissolution profile of each active ingredient dissolved from a drug tablet. In our study, we report a novel non-manual-operation method for performing the automatic dissolution testing of drug tablets, by combining a program-controlled sequential analysis and high-speed capillary electrophoresis for efficient separation of active ingredients. The feasibility of the method for dissolution testing of real drug tablets as well as the performance of the proposed system has been demonstrated. The accuracy of drug dissolution testing is ensured by the excellent repeatability of the sequential analysis, as well as the similarity of the evaluation of dissolution testing. Our study show that the proposed method is capable to achieve simultaneous dissolution testing of multiple ingredients, and the matrix interferences can be avoided. Therefore it is of potential valuable applications in various fields of pharmaceutical research and drug regulation.
Highlights
A methodology for dissolution testing should be capable to trace the evolution of any active pharmaceutical ingredients in a drug from the beginning to the end of the dissolution process[12,13]
We develop a LabVIEW program to automatic control the position of the solenoid valve for sample injection and to turn on/off the high voltage power supply for high-speed capillary electrophoresis (HSCE)
The validation of analytical methodology is carried out according to FDA45 (Food and Drug Administration) guidelines, including accuracy, precision, limit of detection (LOD), limit of quantitation (LOQ) and linearity
Summary
A methodology for dissolution testing should be capable to trace the evolution of any active pharmaceutical ingredients in a drug from the beginning to the end of the dissolution process[12,13]. This requires both high-temporal resolution and high-efficient separation The former is important to obtain the dissolution kinetics of immediate-release drug tablets which dissolve so rapidly, while the latter is a pivotal requirement for dissolution testing of fixed-combination drug tablets which have two or more active pharmaceutical ingredients. The method relies on a program-controlled sequential analysis of drug dissolution, integrating a flow-through-cell of pharmacopoeial dissolution apparatus, an automatic sequential sample injection for high-temporal resolution analysis and HSCE for efficient separation and detection. The key issue to achieve on-line dissolution testing with high-temporal resolution using the proposed system is to automatically control the timing of the sequential sample injection and HSCE separation/ detection. The cumulative amount percentage of the drug dissolved (Dissolved %) from a tablet in time t was used to analyze the dissolution kinetics, which was converted from the experimental measurements using the equation[40], Dissolved
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