Chamberlain Rebecca, Windolf Hellen, Burckhardt Bjoern B, Breitkreutz Jörg, Fischer Björn
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitätsstraße 1, 40225 Düsseldorf, Germany.
Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University, Universitätsstraße 1, 40225 Düsseldorf, Germany.
Pharmaceutics. 2022 Mar 14;14(3):639. doi: 10.3390/pharmaceutics14030639.
Individual dosing of pharmaceutics and personalized medicine have become important with regard to therapeutic safety. Dose adjustments, biorelevant drug release and combination of multiple active substances in one dosage form for the reduction in polymedication are essential aspects that increase the safety and acceptance of the patient's pharmacotherapy. Therefore, not only innovative drug products but also new analytical methods are needed during the drug development phase and for quality control that can simultaneously determine different active ingredients and cover wide concentration ranges. We investigated a liquid-core waveguide UV absorbance flow cell detector coupled to an existing HPLC-UV system. A Teflon AF 2400 capillary tubing of 20 cm length was connected in series to the HPLC flow line and enabled a lower limit of quantification of 1 ng/mL pramipexole (increase in sensitivity by 20 compared to common 0.9 cm flow cells). This allowed the low-concentration of pramipexole and the higher concentrations of levodopa and benserazide occurring during drug release to be determined in a single chromatographic run within 22.5 min.
就治疗安全性而言，药物的个体化给药和个性化医疗已变得至关重要。剂量调整、生物相关性药物释放以及将多种活性物质组合在一种剂型中以减少多重用药，是提高患者药物治疗安全性和可接受性的重要方面。因此，在药物研发阶段以及质量控制过程中，不仅需要创新的药物产品，还需要新的分析方法，这些方法能够同时测定不同的活性成分并覆盖较宽的浓度范围。我们研究了一种与现有的HPLC-UV系统联用的液芯波导紫外吸收流动池检测器。将一根20 cm长的Teflon AF 2400毛细管串联连接到HPLC流路中，使普拉克索的定量下限达到1 ng/mL（与常见的0.9 cm流动池相比，灵敏度提高了20倍）。这使得在单次色谱运行中，能够在22.5分钟内测定药物释放过程中低浓度的普拉克索以及较高浓度的左旋多巴和苄丝肼。
