DiGiacinto J L, Olsen K M, Bergman K L, Hoie E B
Department of Biomedical and Therapeutic Sciences, University of Illinois College of Medicine at Peoria, USA.
Ann Pharmacother. 2000 May;34(5):600-5. doi: 10.1345/aph.19086.
To determine the stability of lansoprazole and omeprazole suspensions at ambient and refrigerated temperatures using HPLC.
The contents of lansoprazole and omeprazole capsules were suspended in separate flasks containing sodium bicarbonate 8.4% to concentrations of 3 and 2 mg/mL, respectively. The contents of each flask were drawn into six amber-colored oral syringes, with one-half of the syringes stored at 22 degrees C (ambient) and the other half at 4 degrees C. Lansoprazole and omeprazole concentrations were determined by a stability-indicating HPLC assay at baseline and at 4, 8, 12, and 24 hours, and on days 4, 7, 14, 21, 30, 45, and 60 after mixing. Both omeprazole and lansoprazole were considered stable if they retained > or =90% of the baseline drug concentration.
Omeprazole was stable for up to 14 days at 22 degrees C and 45 days at 4 degrees C. Lansoprazole was stable for eight hours at 22 degrees C and for 14 days at 4 degrees C.
When compared with ambient or refrigerated storage conditions, omeprazole was stable for a longer duration than lansoprazole. Pharmacists may use these results to guide compounding and storage of proton-pump inhibitor suspensions.
使用高效液相色谱法（HPLC）测定兰索拉唑和奥美拉唑混悬液在室温和冷藏温度下的稳定性。
将兰索拉唑和奥美拉唑胶囊内容物分别悬浮于含有8.4%碳酸氢钠的烧瓶中，使其浓度分别达到3和2mg/mL。将每个烧瓶中的内容物吸入六个琥珀色口服注射器中，其中一半注射器储存在22℃（室温），另一半储存在4℃。通过稳定性指示HPLC法在基线、4、8、12和24小时以及混合后第4、7、14、21、30、45和60天测定兰索拉唑和奥美拉唑的浓度。如果奥美拉唑和兰索拉唑保留的药物浓度≥基线药物浓度的90%，则认为它们是稳定的。
奥美拉唑在22℃下稳定14天，在4℃下稳定45天。兰索拉唑在22℃下稳定8小时，在4℃下稳定14天。
与室温或冷藏储存条件相比，奥美拉唑的稳定时间比兰索拉唑更长。药剂师可利用这些结果指导质子泵抑制剂混悬液的配制和储存。
