快速灵敏测定含蛋白质溶液中的聚山梨酯 80。
Fast and sensitive determination of Polysorbate 80 in solutions containing proteins.
机构信息
Formulation Development, Gedeon Richter Plc, Gyömroi út 19-21, Budapest X., Hungary.
出版信息
J Pharm Biomed Anal. 2010 Sep 5;52(5):672-9. doi: 10.1016/j.jpba.2010.02.035. Epub 2010 Mar 3.
A fast and sensitive method has been developed for the specific determination of Polysorbate 80 (Tween 80) in liquid formulations in the presence of proteins and excipients. The quantitative determination is based on a fast liquid chromatographic (HPLC) separation and charged aerosol detection (CAD). The method was validated using a Poroshell 300SB-C18 column packed with 5 microm shell particles (75 mm x 2.1 mm) and acetonitrile-methanol-water-trifluoroacetic acid mobile phase at a flow rate of 0.65 ml/min. The rapid LC-CAD method is suitable for quantifying Polysorbate 80 in the range of 10-60 microg/ml in protein solutions within good manufacturing practices (GMPs) of the pharmaceutical industry.
已开发出一种快速灵敏的方法，用于在存在蛋白质和赋形剂的情况下，对液体制剂中的聚山梨酯 80（吐温 80）进行特异性定量测定。定量测定基于快速液相色谱（HPLC）分离和带电气溶胶检测（CAD）。该方法使用 Poroshell 300SB-C18 柱进行验证，该柱填充有 5 微米壳颗粒（75 毫米 x 2.1 毫米），流动相为乙腈-甲醇-水-三氟乙酸，流速为 0.65ml/min。该快速 LC-CAD 方法适用于在制药行业的良好生产规范（GMP）范围内，在蛋白质溶液中定量测定 10-60μg/ml 范围内的聚山梨酯 80。
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