The amount of polysorbate 80 in pharmaceutical formulations affects the product quality and efficacy. A reliable test method is required to quantify the amount of Polysorbate 80 present in the drug product formulations. The test method for the determination of Polysorbate 80 may be used during process development and final product quality assessment. A simple, fast and efficient quantitative method, making use of HPLC-ELSD and a C18 column without sample pretreatment was developed. The developed method demonstrated specificity to polysorbate 80 with high precision as indicated by percent relative standard deviation (%RSD) of 3.0% for six determinations. The accuracy of this method for the determination of polysorbate 80 in a pharmaceutical formulation was demonstrated with an overall recovery of 94.9%.

药物制剂中的聚山梨酯80的量会影响产品质量和功效。需要可靠的测试方法来量化药物制剂中存在的聚山梨酯80的量。用于测定聚山梨酯80的测试方法可用于工艺开发和最终产品质量评估。开发了一种简单，快速，高效的定量方法，该方法使用了HPLC-ELSD和无需样品预处理的C18色谱柱。所开发的方法显示了对聚山梨酯80的高度精确性，如六次测定的相对标准偏差百分数（％RSD）为3.0％所示。证实了该方法测定药物制剂中聚山梨酯80的准确性，总回收率为94.9％。