Ravuconazole (RAV) is a triazole antifungal with broad spectrum and a novel alternative in the treatment of systemic fungal infections. A stability-indicating method by high-performance liquid chromatography–diode array detection was developed and fully validated to assay ravuconazole in the presence of its degradation products. Separation was achieved with a Sunfire C18 column (250 mm × 4.6 mm id, 5 μm), mobile phase composed of acetonitrile and water (80:20), at 1 mL/min. The volume of injection was 5 μL and DAD detection was performed at 287 nm. RAV was well resolved from its degradation products and the method proved to be linear, selective, accurate, precise and robust. A forced degradation study was conducted on the pure drug under oxidative conditions in presence of H2O2 and metallic ions and under acid, alkaline and neutral hydrolysis. RAV was degraded mainly under alkaline hydrolysis, forming two main degradation products. The chemical structures were proposed according to the data obtained by liquid chromatography coupled to mass spectrometry (LC-MS) analysis. This study provided a new and selective stability-indicating method to evaluate the intrinsic stability of ravuconazole in active pharmaceutical ingredients. The developed method was found to be suitable for quality control routine analysis and to stability studies of ravuconazole.

中文翻译：

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通过 HPLC-DAD 和 MS 表征雷伏康唑强制降解产物的稳定性指示测定方法的开发

雷武康唑（RAV）是一种广谱三唑类抗真菌药，是治疗全身性真菌感染的一种新型替代品。开发了一种通过高效液相色谱 - 二极管阵列检测的稳定性指示方法，并在其降解产物存在的情况下对其进行了充分验证，以测定雷伏康唑。使用 Sunfire C18 色谱柱（250 mm × 4.6 mm id，5 μm）进行分离，流动相由乙腈和水 (80:20) 组成，流速为 1 mL/min。进样量为 5 μL，在 287 nm 处进行 DAD 检测。RAV 很好地从其降解产物中分离出来，并且该方法被证明是线性的、选择性的、准确的、精确的和稳健的。在 H2O2 和金属离子存在的氧化条件下，以及在酸、碱和中性水解下，对纯药物进行了强制降解研究。RAV主要在碱性水解下降解，形成两种主要的降解产物。根据液相色谱-质谱联用 (LC-MS) 分析获得的数据提出化学结构。本研究提供了一种新的选择性稳定性指示方法，用于评估雷乌康唑在活性药物成分中的内在稳定性。发现所开发的方法适用于质量控制常规分析和雷夫康唑的稳定性研究。本研究提供了一种新的选择性稳定性指示方法，用于评估雷乌康唑在活性药物成分中的内在稳定性。发现所开发的方法适用于质量控制常规分析和雷夫康唑的稳定性研究。本研究提供了一种新的选择性稳定性指示方法，用于评估雷乌康唑在活性药物成分中的内在稳定性。发现所开发的方法适用于质量控制常规分析和雷夫康唑的稳定性研究。