高效液相色谱法测定扎那米韦鼻用粉雾剂含量和相关杂质的研究  

Determination of related substances and assay of zanamivir nasal powder by HPLC method

作　　者：井绪文 吴优 李柏林 陈顺 王泽人 JING Xu-wen;WU You;LI Bo-lin;CHEN Shun;WANG Ze-ren(Shenzhen HLK Pharmaceuticals,Co.,Ltd.,Shenzhen 518057,China;Nanjing University Shenzhen Research Institute,Shenzhen 518057,China)

机构地区：[1]深圳市华力康生物医药有限公司,深圳518057 [2]南京大学深圳研究院,深圳518057

出　　处：《中国新药杂志》2018年第20期2447-2450,共4页Chinese Journal of New Drugs

基　　金：深圳市科技研发资金资助项目(JSGG20141016145810835)

摘　　要：目的:建立检测扎那米韦鼻用粉雾剂的相关杂质和含量的HPLC方法。方法:色谱柱为ECHWAY JADE-PAK ODS-AQC18柱(250 mm×4. 6 mm,5μm);流动相为甲醇-0. 2%辛烷磺酸钠溶液(0. 1 mol·L-1氢氧化钠调节pH 6. 0)=5∶95;流速为0. 7 m L·min-1;柱温为30℃;检测波长为234 nm。结果:本方法系统适用性实验符合要求,扎那米韦鼻用粉雾剂主成分与各降解成分的分离度及检测灵敏度均可满足相关杂质和含量的检测,扎那米韦在0. 15~720μg·m L-1浓度范围内线性良好。结论:本法简便、灵敏,可用于扎那米韦鼻用粉雾剂的相关杂质和含量的检查。Objective： To establish an HPLC method for determination of the related substances and assay of zanamivir nasal powder. Methods： ECHWAY JADE-PAK ODS-AQ C18 column（ 250 mm × 4. 6 mm,5 μm） was used with methanol-0. 2% sodium octane sulfonate aqueous solution（ adjust pH to 6. 0 with 0. 1 mol·L-1 NaOH solution） =（ 5∶ 95） as mobile phase. Flow rate was 0. 7 m L·min-1. The detection wavelength was set at 234 nm and the column temperature maintained at 30 ℃. Results： The system suitability experiment of this method meets the requirements. The separation and detection sensitivity could meet the detection and assay demand of main components of zanamivir nasal powder and related degradation impurities. The linearity was satisfied in the contents ranging within 0. 15 - 720 μg·m L-1. Conclusions： The established method is simple,sensitive. It can be applied in the determination of related substances and assay of zanamivir nasal powder.

关 键 词：扎那米韦 相关杂质 鼻用粉雾剂 

分 类 号：R917[医药卫生—药物分析学]