Pramlintide acetate (Symlin®), a synthetic analogue of the human hormone amylin. It was approved in March 2005 as a subcutaneous injection for the adjunctive treatment of patients who have type 1 or 2 diabetes mellitus. The objective of current investigation was to study the degradation behavior of pramlintide acetate under different ICH recommended stress conditions by HPLC and LC-MS. Pramlintide acetate was subjected to stress conditions of hydrolysis (acidic or alkaline), oxidation, photolysis and thermal decomposition. Extensive degradation products were observed under the hydrolysis, oxidation or thermal stress conditions, while minimal degradation was found in the photolytic conditions. Successful separation of drug from the degradation products was achieved by the validated chromatography (RP-HPLC and SCX-HPLC) methods. Subsequent to isolation, the molecular weight of each component was determined by LC-MS. The LC-MS m/z values and fragmentation patterns of 4 impurities matched with the predicted degradation products of pramlintide acetate.

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HPLC和LC-MS对醋酸普兰林肽强制降解行为的研究

醋酸普兰林肽 (Symlin®)，一种人类激素胰淀素的合成类似物。它于 2005 年 3 月被批准作为皮下注射剂用于 1 型或 2 型糖尿病患者的辅助治疗。目前研究的目的是通过 HPLC 和 LC-MS 研究醋酸普兰林肽在不同 ICH 推荐的应力条件下的降解行为。醋酸普兰林肽经受水解（酸性或碱性）、氧化、光解和热分解的应力条件。在水解、氧化或热应力条件下观察到大量的降解产物，而在光解条件下发现的降解最小。通过经过验证的色谱法（RP-HPLC 和 SCX-HPLC）方法成功地从降解产物中分离药物。分离后，通过 LC-MS 测定各组分的分子量。4 种杂质的 LC-MS m/z 值和碎裂模式与预测的醋酸普兰林肽降解产物相匹配。