Fleming Kelly, Donnelly Ronald F
The Ottawa Hospital, Ottawa, Ontario, Canada.
Hosp Pharm. 2019 Feb;54(1):32-36. doi: 10.1177/0018578718763085. Epub 2018 Mar 7.
The physical compatibility and chemical stability of ranitidine hydrochloride injectable solutions and oral syrup were studied to define beyond-use dates (BUDs). Ranitidine hydrochloride injectable solutions of 25 mg/mL packaged in glass vials and 5 mg/mL in polypropylene (PP) syringes were prepared in triplicate. Samples were refrigerated and protected from light (PFL) or stored at 25°C and either exposed to light (ETL) or PFL. Ranitidine hydrochloride oral syrup 15 mg/mL in unit-dose amber PP syringes were prepared in triplicate and then kept at 25°C. Samples were collected at days 0, 7, 14, 28, 56, and 91. Additional samples were collected at 6 months and at 6, 9, and 12 months for the 25 mg/mL solution and oral syrup, respectively. Physical parameters of pH, clarity, and color were obtained at each collection time. A validated stability-indicating high-performance liquid chromatography (HPLC) method was used to determine the chemical stability. Formulations had no significant change in pH or clarity. Although some samples yellowed, this was not associated with a decrease in concentration. The 25 mg/mL solution remained above 98.6% for 6 months, whereas the 5 mg/mL solution remained above 93.5% for 91 days under all storage conditions. At 25°C, the oral syrup retained greater than 98.8% for 12 months. The ranitidine hydrochloride injectable solutions were stable for 6 months and 91 days under the 3 storage conditions, respectively, for the 25 mg/mL solution in glass vials and 5 mg/mL solution in PP syringes. The 15 mg/mL oral syrup in unit-dose amber PP syringes was stable for 12 months at 25°C and PFL.
研究了盐酸雷尼替丁注射液和口服糖浆的物理相容性及化学稳定性，以确定其使用期限（BUDs）。制备了一式三份包装于玻璃小瓶中的25 mg/mL盐酸雷尼替丁注射液及装于聚丙烯（PP）注射器中的5 mg/mL盐酸雷尼替丁注射液。样品冷藏并避光保存（PFL），或于25°C保存，分为光照（ETL）或避光（PFL）两组。制备了一式三份装于单剂量琥珀色PP注射器中的15 mg/mL盐酸雷尼替丁口服糖浆，然后于25°C保存。在第0、7、14、28、56和91天采集样品。对于25 mg/mL溶液和口服糖浆，分别在6个月时以及6、9和12个月时采集额外样品。在每次采集时间获取pH、澄清度和颜色等物理参数。采用经过验证的稳定性指示高效液相色谱（HPLC）法测定化学稳定性。制剂的pH或澄清度无显著变化。虽然一些样品变黄，但这与浓度降低无关。在所有储存条件下，25 mg/mL溶液6个月内含量保持在98.6%以上，而5 mg/mL溶液91天内含量保持在93.5%以上。在25°C下，口服糖浆12个月内含量保持在98.8%以上。对于玻璃小瓶中的25 mg/mL溶液和PP注射器中的5 mg/mL溶液，盐酸雷尼替丁注射液在3种储存条件下分别稳定6个月和91天。装于单剂量琥珀色PP注射器中的15 mg/mL口服糖浆在25°C和避光条件下稳定12个月。
