反相离子对高效液相色谱法检查盐酸伊立替康(CPT-11)有关物质

目的:采用反相离子对高效液相色谱法优化盐酸伊立替康中有关物质的检查方法。 方法:采用C₁₈色谱柱(150 mm×4.6 mm,5 μm),以甲醇-20 mmol·L^-1 磷酸氢二钠溶液(含7.7 mmol·L^-1辛烷磺酸钠)(50: 50)为流动相进行等度洗脱,检测波长为255 nm,柱温 40℃。 结果:经优化的反相离子对色谱法明显改善了盐酸伊立替康和各有关物质的保留行为及分离情况,色谱运行总时间不超过10 min。进一步通过强制降解试验验证了该色谱方法的专属性。 结论:本方法简单快速,有利于满足伊立替康有关物质检查的质量控制要求。

Objective: To optimize the testing method of irinotecan hydrochloride and its related substances by reversed-phase ion-pair high performance chromatography (RP-HPLC). Methods: The optimized separation was operated on a C₁₈ column(150 mm×4.6 mm,5 μm)with an isocratic mobile phase composed of methanol- 20 mmol·L ^-1 disodium hydrogen phosphate (containing 7.7 mmol·L^-1 octane sulfonate) (50: 50).The column temperature was set at 40℃ and the UV detection wavelength was 255 nm. Results: The RP-HPLC method significantly improved the retention behavior and separation of irinotecan hydrochloride and its related substances.The total operation time was no more than 10 min.Specificity was further assessed though the forced degradation tests. Conclusion: The optimized method is rapid and sensitive which is practical in accordance with the quality control requirement of testing the related substances in irinotecan hydrochloride.

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