HPLC法测定VHP灭菌后滴眼剂瓶胶塞过氧化氢残留量  

Determination of Residual Hydrogen Peroxide in VHP Sterilized Eye Drops Bottle Stoppers by HPLC Method

作　　者：杜传龙 陈珍珍 张周洋 宋佳 王鑫源 DU Chuanlong;CHEN Zhenzhen;ZHANG Zhouyang;SONG Jia;WANG Xinyuan

机构地区：[1]江西省药品检查员中心,江西南昌330006 [2]马应龙药业集团股份有限公司,湖北武汉430064

出　　处：《化工设计通讯》2024年第10期110-113,共4页Chemical Engineering Design Communications

基　　金：江西省药品监督管理局科研项目(2023GL19)。

摘　　要：旨在研究药用滴眼剂瓶胶塞经过VHP灭菌后表面残留的过氧化氢含量的检测方法。采用HPLC法对胶塞表面过氧化氢的残留量进行检测,并对该方法进行方法学验证。HPLC法测试低密度聚乙烯药用滴眼剂瓶瓶塞过氧化氢的残留的测定方法,专属性良好,线性、检测限、定量限、系统适应性、准确度、精密度(重复性和中间精密度)、耐用性,溶液稳定性均满足要求。所建立的方法操作简便,准确灵敏,专属性强,重复性好;可用于VHP灭菌后胶塞表面过氧化氢残留量的测定。This article aims to study the detection method of residual hydrogen peroxide content on the surface of the rubber stopper of medicinal eye drops after VHP sterilization.HPLC was used to detect the residual amount of hydrogen peroxide on the surface of the rubber stopper,and the method was validated.The HPLC method for determining the residual hydrogen peroxide in low-density polyethylene pharmaceutical eye drops bottle stopper products has good specificity,linearity,detection limit,quantification limit,system adaptability,accuracy,precision(repeatability and intermediate precision),durability,and solution stability all meet the requirements.The established method is easy to operate,accurate,sensitive,highly specific,and has good reproducibility;Can be used for the determination of residual hydrogen peroxide on the surface of rubber plugs after VHP sterilization.

关 键 词：HPLC法 滴眼剂瓶胶塞 VHP灭菌 过氧化氢残留 

分 类 号：R927.2[医药卫生—药学] O657.72[理学—分析化学]