Mondal Bikash, Kote Mahesh, Lunagariya Chandrakant, Patel Milan
Research and Development, Akorn Pharmaceuticals, 50 Lake View Parkway, Suite#112, Vernon Hills, IL, 60061, United States.
Saudi Pharm J. 2020 Mar;28(3):325-328. doi: 10.1016/j.jsps.2020.01.012. Epub 2020 Jan 31.
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%.
药物制剂中聚山梨酯80的含量会影响产品质量和疗效。需要一种可靠的测试方法来定量药物制剂中聚山梨酯80的含量。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、快速且高效的定量方法，该方法利用高效液相色谱-蒸发光散射检测器（HPLC-ELSD）和C18柱，无需样品预处理。所开发的方法对聚山梨酯80具有特异性，精密度高，六次测定的相对标准偏差（%RSD）为3.0%。该方法测定药物制剂中聚山梨酯80的准确性得到了验证，总体回收率为94.9%。
