Severin G
J Pharm Sci. 1986 Feb;75(2):211-4. doi: 10.1002/jps.2600750224.
In vitro dissolution testing of solid pharmaceutical dosage forms has become a routine aspect of data collection for new product submissions and quality control purposes. With increasing frequency, dissolution testing is performed in buffered media, including low pH simulated gastric fluid and/or alkaline pH simulated intestinal fluid. High-performance liquid chromatographic separation of multicomponent formulations is the most convenient method of quantitation for dissolution samples in such aqueous media; however, particularly in the analytical methodology of drugs containing basic moieties, the direct injection of dissolution media may cause spurious peaks, base line disturbances, and other manifestations of column disequilibration. Using a column packing consisting of 16% w/w alumina in unbonded silica and aqueous mobile phases buffered with monofluorophosphate ion, it is possible to achieve stability in a system exposed to injections differing from the mobile phase in pH and composition.
固体药物剂型的体外溶出度测试已成为新产品申报和质量控制数据收集的常规环节。溶出度测试越来越频繁地在缓冲介质中进行，包括低pH值模拟胃液和/或碱性pH值模拟肠液。对于此类水性介质中的溶出样品，高效液相色谱法分离多组分制剂是最便捷的定量方法；然而，特别是在含有碱性基团药物的分析方法中，直接进样溶出介质可能会导致出现假峰、基线干扰以及柱不平衡的其他表现。使用由16%（w/w）氧化铝负载于未键合硅胶上的柱填料和用单氟磷酸根离子缓冲的水性流动相，能够在一个暴露于pH值和组成与流动相不同的进样系统中实现稳定性。
