HPLC测定依托泊苷胶丸的有关物质

 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-Bondapak Phenyl(300 mm×3.9 mm，5μm)；柱温：45℃；甲醇-水为流动相，梯度洗脱，流速：1.0 mL·min^-1；检测波长：240 nm。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4.9，6.2，13.6，26.2，11.2，8.1，23.6 ng。结论本法准确可靠，灵敏度高。

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

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·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 23.6ng respectively. CONCLUTIONS The method appeared to be accurate and sensitive.