HPLC测定依托泊苷胶丸的有关物质

Establishment of a HPLC assay for determination of related substances of etoposide capsules

目的 建立依托泊苷胶丸的有关物质 [木酚素P ,4′ 去甲基鬼臼素 ,α 亚乙基木酚素P ,苦亚乙基木酚素P ,4′ 苄酯基亚乙基木酚素P和 4′ 苄酯基二甲酰基亚乙基木酚素P]的HPLC测定方法。方法 HPLC色谱条件 :色谱柱为Micro BondapakPhenyl(30 0mm× 3.9mm ,5 μm) ;柱温 :4 5℃ ;甲醇 水为流动相 ,梯度洗脱 ,流速 :1.0mL·min-1;检测波长 :2 4 0nm。结果 依托泊苷与各杂质及赋形剂的分离良好 ;木酚素P ,4′ 去甲基鬼臼素 ,依托泊苷 ,α 亚乙基木酚素P ,苦亚乙基木酚素P ,4′ 苄酯基亚乙基木酚素P和 4′ 苄酯基二甲酰基亚乙基木酚素P的最低检测量分别为 4 .9,6 .2 ,13.6 ,2 6 .2 ,11.2 ,8.1,2 3.6ng。 结论 本法准确可靠 ,灵敏度高。

OBJECTIVE: To develop a HPLC assay for the determination of related substances of etoposide capsules. METHODS: The analysis was conducted on Phenyl column with a mobile phase of methanol-water by gradient elution at a flow of 1.0 mL &middot min-1. The detection wavelength was at 240 nm. RESULTS: Good resolution of etoposide, excipient and related substances was obtained. The detection limits of lignan P, 4-demethylepipodophyllotoxin, etoposide, alpha-ethylidene lignan P, picroethylidene lignan P, 4′-carbobenzoxy ethylidene lignan P, 4′-carbobenzoxy diformyl ethylidene lignan P were 4.9,6.2,13.6,26.2,11.2,8.1 and 23.6 ng respectively. CONCLUTIONS: The method appeared to be accurate and sensitive.