目的:建立了高效液相色谱法测定具有烯醇互变结构的鲁比前列酮有关物质方法.方法:采用Li Chrospher100 Diol, (250 mm×4. 0 mm, 5μm) Merck色谱柱, 以正己烷:无水乙醇:冰醋酸 (500∶40∶1) 的混合溶液为流动相, 等度洗脱, 检测波长294 nm.结果:在该色谱条件下, 各杂质和鲁比前列酮之间的分离度均能达到1. 5以上;各有关物质的检测限为相当于主成分浓度的0. 03％;鲁比前列酮及其有关物质在各自限度范围内线性良好 (r≥0. 990, n=6) ;各杂质的准确度均在95. 0％～100. 0％之间 (RSD≤5. 0) .结论:本方法可用于鲁比前列酮有关物质的检测.%An HPLC method was established for the determination of related substancesof lubiprostone drug substance with enol tautomer structure. Method: A Li Chrospher 100 Diol, ( 250 mm × 4. 0 mm, 5 μm) Merck was used, with the mobile phase of hexane: ethanol and acetic acid ( 500 ∶ 40 ∶ 1) , The elution was isocratic and the detectionwavelength of 294 nm. Results:Under this chromatographic condition, the degree of separation between each impurity and lubiprostone can reach 1. 5 or more; the detection limit of each related substance is equivalent to 0. 03％of the main component concentration; lubiprostone and its related substances were linear in the self-concentration range ( r ≥ 0. 990, n = 6) . The accuracy of each impurity was between 95. 0％ and 100. 0％ ( RSD ≤ 5. 0) .Conclusion:The established method is suitablefor the determination of related substances in lubiprostone.
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