Keyi X, Gagnon N, Bisson C, Desmarais M, LeBel M
Laboratoire de Pharmacocinétique Clinique, Université Laval, Québec, Canada.
Ann Pharmacother. 1993 Apr;27(4):422-6. doi: 10.1177/106002809302700404.
(1) to determine the stability of famotidine 200 micrograms/mL in admixtures with dextrose 5% injection (D5W) and NaCl 0.9% injection (NS) in polyvinyl chloride (PVC) minibags and polypropylene syringes, at room temperature (22 degrees C), protected and unprotected from light for 15 days; and (2) to evaluate the visual compatibility of famotidine with 34 selected drugs for four hours at room temperature.
Concentration of famotidine samples was determined on day 0 and again on days 3, 6, 9, 12, and 15 by a stability-indicating HPLC. Inspection for visual and pH changes was also performed at these time intervals.
More than 95 percent of the day 0 famotidine concentration remained in all samples over the 15-day study period. During this period, all samples remained clear and colorless and no change in absorbance at 450 and 540 nm was observed. The pH of the samples also remained unchanged. Famotidine 2000 micrograms/mL was found to be compatible with 33 selected drugs; only furosemide was found to be incompatible. A white precipitate was observed when an equal volume of famotidine 2000 micrograms/mL in NS was mixed with furosemide 3000 micrograms/mL in D5W. The concentration of famotidine in the supernatant gradually decreased during the 4-hour study period. At 0.5, 1.0, 2.0, and 4.0 hours after mixture of famotidine with furosemide, famotidine concentrations were 97.5, 23.6, 21.7, and 17.2 percent of the initial famotidine concentration, respectively.
Our results show that famotidine 200 micrograms/mL was stable in admixture with D5W and NS in PVC minibags and polypropylene syringes when these solutions were stored at room temperature, protected and unprotected from light for 15 days. Famotidine 2000 micrograms/mL in NS was compatible with 33 of the drugs, and was incompatible with furosemide.
（1）测定200微克/毫升法莫替丁与5%葡萄糖注射液（D5W）和0.9%氯化钠注射液（NS）在聚氯乙烯（PVC）迷你袋和聚丙烯注射器中混合后，于室温（22摄氏度）下，在有光和无光条件下保存15天的稳定性；（2）评估法莫替丁与34种选定药物在室温下4小时的视觉相容性。
通过稳定性指示高效液相色谱法在第0天以及第3、6、9、12和15天测定法莫替丁样品的浓度。在这些时间间隔也进行了外观和pH值变化检查。
在为期15天的研究期间，所有样品中第0天法莫替丁浓度的95%以上得以保留。在此期间，所有样品均保持澄清无色，在450和540纳米处未观察到吸光度变化。样品的pH值也保持不变。发现2000微克/毫升法莫替丁与33种选定药物相容；仅发现呋塞米不相容。当等体积的2000微克/毫升法莫替丁在NS中与3000微克/毫升呋塞米在D5W中混合时，观察到白色沉淀。在4小时的研究期间，上清液中法莫替丁的浓度逐渐降低。法莫替丁与呋塞米混合后0.5、1.0、2.0和4.0小时，法莫替丁浓度分别为初始法莫替丁浓度的97.5%、23.6%、21.7%和17.2%。
我们的结果表明，200微克/毫升法莫替丁与D5W和NS在PVC迷你袋和聚丙烯注射器中混合后，于室温下有光和无光条件下保存时，15天内是稳定的。2000微克/毫升法莫替丁在NS中与33种药物相容，与呋塞米不相容。
