Determining the suitability of mass spectrometry for understanding the dissolution processes involved with pharmaceutical tablets.

摘要: RATIONALE: A current challenge for analytical chemists is the development of measurement systems and approaches required to understand dynamic processes such as tablet dissolution. The design oral tablets could be improved by availability detailed information about rates release individual components. Small footprint mass spectrometry (MS) are gaining use on-line reaction monitoring because their ability rapidly determine multiple reactant, intermediate, product species. We have therefore assessed utility MS study dissolution processes. METHODS: Aqueous media containing phosphate other non volatile buffer salts were pumped from a standard USPII vessel through an active splitter back. sampled stream diluted it into make-up flow which was small single quadrupole spectrometer. Single ion used quantify ions interest. Three different bio-relevant studied gauge impact sample matrix. RESULTS: Individual profiles obtained three drugs lactose soluble filler. This successfully demonstrated with designed reflect pH sections human gastro-intestinal tract. Component concentrations low 0.06 μg/mL (representing 1% dissolution) detected. correlated visual observation gave linear responses concentration components, although analysis solution indicated that suppression area further investigation CONCLUSIONS: An system they released same tablet. level each these components in determined every 10 seconds, had similar profile. using inorganic solutions at pHs.