Thiowurtzine, a hexaazaisowurtzitane derivate, is a novel original non-opioid analgesic. In this article, an HPLC–UV method has been developed for rapid detection and quantification of API and related substances contained in thiowurtzine capsules. Six thiowurtzine impurities were separated successfully from each other by isocratic elution using a Luna 5u PFP (2) (150 mm × 4.6 mm, 5 µm) column with 30 µL injection volumes at a wavelength of 254 nm. Commercially unavailable impurities were formed by degradation of thiowurtzine and preliminarily identified by high-resolution LC–MS. This method proved to be robust, linear, repeatable, sensitive, selective and handy.

中文翻译：

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开发同时测定硫柳碱中 API 和相关成分的 HPLC 方法：一种新型非麻醉性镇痛剂

Thiowurtzine 是一种六氮杂异武兹烷衍生物，是一种新型的原始非阿片类镇痛剂。在本文中，开发了一种 HPLC-UV 方法，用于快速检测和定量硫纤锌矿胶囊中的 API 和相关物质。使用 Luna 5u PFP (2)（150 mm × 4.6 mm，5 µm）色谱柱，进样体积为 30 µL，波长为 254 nm，通过等度洗脱成功分离了六种硫纤锌矿杂质。商业上无法获得的杂质是由硫纤锌矿降解形成的，并通过高分辨率 LC-MS 初步鉴定。该方法被证明是稳健的、线性的、可重复的、灵敏的、选择性的和方便的。