Rochani Ankit, Nguyen Vinh, Becker Robin, Kraft Walter, Kaushal Gagan
J Pediatr Pharmacol Ther. 2021;26(4):395-404. doi: 10.5863/1551-6776-26.4.395. Epub 2021 May 19.
In the hospital settings, buprenorphine is used for the treatment of patients with neonatal abstinence syndrome. It is extemporaneously compounded and stored in oral plastic syringes. However, limited information exists about the stability of buprenorphine and its compounded formulations when stored under specific conditions. Hence, we developed a stability-indicating high-performance liquid chromatography-mass spectrometry (LC-MS) method to analyze the stability of buprenorphine over time.
A stability-indicating LC-MS method was developed to map the potential degradation peaks of buprenorphine when exposed to acidic, basic, and oxidative conditions. This method was used to study the stability of compounded buprenorphine oral syringes stored under refrigeration (2°C-8°C) and room temperature (25°C ± 2°C with 60% relative humidity). Syringes from each storage condition were assessed for stability using pH meter and stability-indicating LC-MS assay for 30 days.
Buprenorphine gets completely degraded in the presence of acid at the end of 1 hour of exposure. Various degradation peaks were identified using LC-MS assay for buprenorphine under acidic, basic, and peroxide conditions. Stability study of oral buprenorphine syringes showed no precipitation, cloudiness, or color change during this study at all storage conditions. The LC-MS assay revealed that buprenorphine oral syringes retained greater than 90% of the initial concentrations for 30 days.
Highly sensitive stability-indicating LC-MS method was developed for studying the stability of extemporaneously compounded buprenorphine oral syringes. This study demonstrates that buprenorphine extemporaneous formulation prepared according to the manufacturers' recommendations is stable under refrigerated or room temperature conditions for 30 days in oral plastic syringes.
在医院环境中，丁丙诺啡用于治疗新生儿戒断综合征患者。它是临时配制并储存在口服塑料注射器中。然而，关于丁丙诺啡及其配制制剂在特定条件下储存时的稳定性信息有限。因此，我们开发了一种稳定性指示高效液相色谱 - 质谱（LC - MS）方法来分析丁丙诺啡随时间的稳定性。
开发了一种稳定性指示LC - MS方法，以确定丁丙诺啡在酸性、碱性和氧化条件下的潜在降解峰。该方法用于研究冷藏（2°C - 8°C）和室温（25°C ± 2°C，相对湿度60%）下储存的丁丙诺啡口服注射器的稳定性。使用pH计和稳定性指示LC - MS测定法对每种储存条件下的注射器进行30天的稳定性评估。
丁丙诺啡在暴露于酸1小时结束时完全降解。使用LC - MS测定法在酸性、碱性和过氧化物条件下鉴定了丁丙诺啡的各种降解峰。丁丙诺啡口服注射器的稳定性研究表明，在所有储存条件下，本研究期间均未出现沉淀、浑浊或颜色变化。LC - MS测定显示，丁丙诺啡口服注射器在30天内保持初始浓度的90%以上。
开发了高灵敏度的稳定性指示LC - MS方法来研究临时配制的丁丙诺啡口服注射器的稳定性。本研究表明，根据制造商建议制备的丁丙诺啡临时制剂在冷藏或室温条件下于口服塑料注射器中30天内是稳定的。
