Development of a simple high performance liquid chromatography (HPLC)/evaporative light scattering detector (ELSD) method to determine Polysorbate 80 in a pharmaceutical formulation

被引:15
作者
Mondal, Bikash [1 ]
Kote, Mahesh [1 ]
Lunagariya, Chandrakant [1 ]
Patel, Milan [1 ]
机构
[1] Akorn Pharmaceut, Res & Dev, 50 Lake View Pkwy,Suite 112, Vernon Hills, IL 60061 USA
关键词
Method development; HPLC; ELSD; Polysorbate; 80; Pharmaceutical formulation; HPLC; MS;
D O I
10.1016/j.jsps.2020.01.012
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
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%. (C) 2020 Published by Elsevier B.V. on behalf of King Saud University.
引用
收藏
页码:325 / 328
页数:4
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