Non-depolarizing neuromuscular blocking agent Rocuronium bromide was quantified in drug substance and drug product using reversed-phase liquid chromatographic method. Forced degradation studies were conducted for Rocuronium bromide in drug substance under acidic (2MHCl), basic (2MNaOH), oxidative (3% H2O2), thermal (135°C) and photolytic (254 nm) stress conditions. An Agilent H12 C18 column was used for separation using diammonium hydrogen phosphate buffer (pH 8; 0.04M)- acetonitrile (50:50; v/v) as mobile phase at flow rate of 1 mL/min. The quantification was done using UV detection at 210 nm. The limit of quantification and detection was 11.1 and 3.66 μg/mL, respectively, and the recovery percentage was 99% in drug substance and drug product. ICH guidelines were adopted for method validation. The proposed LC method monitored the degradation profile for Rocuronium bromide under various stress conditions and provided a specific LC method for its routine analysis. Besides, the MS data were used to identify all Rocuronium bromide degradation products and the possible degradation pathway was designated.

中文翻译：

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ICH 指南在罗库溴铵降解行为研究中的应用与稳定性指示 RP-LC 方法相结合

采用反相液相色谱法对原料药和制剂中的非去极化神经肌肉阻滞剂罗库溴铵进行定量。在酸性 (2MHCl)、碱性 (2MNaOH)、氧化 (3% H2O2)、热 (135°C) 和光解 (254 nm) 应力条件下，对药物中的罗库溴铵进行了强制降解研究。使用 Agilent H12 C18 色谱柱进行分离，使用磷酸氢二铵缓冲液 (pH 8; 0.04M)-乙腈 (50:50; v/v) 作为流动相，流速为 1 mL/min。使用 210 nm 的 UV 检测进行定量。原料药和制剂的定量限和检出限分别为11.1和3.66 μg/mL，回收率为99%。方法验证采用 ICH 指南。所提出的液相色谱方法监测了罗库溴铵在各种压力条件下的降解曲线，并为其常规分析提供了一种特定的液相色谱方法。此外，MS数据用于鉴定所有罗库溴铵降解产物，并指定了可能的降解途径。