A Highly Sensitive Method for the Quantitation of Polysorbate 20 and 80 to Study the Compatibility between Polysorbates and m-Cresol in the Peptide Formulation
Shuai Shi, Zhi Chen*, Joseph M Rizzo, Andrew Semple, Sarita Mittal, Jason K Cheung, Daisy Richardson, Valentyn Antochshuk and Mohammed Shameem
Sterile Product and Analytical Development, BioProcess Development, Merck Research Laboratories, Merck & Co, Kenilworth, NJ 07033, USA
- *Corresponding Author:
- Zhi Chen
Sterile Product and Analytical Development, BioProcess Development
Merck Research Laboratories, Merck & Co
Kenilworth, NJ 07033, USA
Tel: +1 908-740-6798
E-mail: [email protected]
Received date: March 16, 2014; Accepted date: May 05, 2015; Published date: May 12, 2015
Citation: Shi S, Chen Z, Rizzo JM, Semple A, Mittal S, et al. (2015) A Highly Sensitive Method for the Quantitation of Polysorbate 20 and 80 to Study the Compatibility between Polysorbates and m-Cresol in the Peptide Formulation. J Anal Bioanal Tech 6: 245. doi: 10.4172/2155-9872.1000245
Copyright: © 2015 Shi S, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
A highly sensitive method has been developed for the quantitation of polysorbate 20 (PS20) and 80 (PS80) in therapeutic peptide formulations. A mixed-mode HPLC column was used to separate polysorbates from the peptide and other excipients, and a charged aerosol detector (CAD) was used for the detection. The method was capable of reporting polysorbates as low as 5 ppm, and the sensitivity could be further improved on a needed basis. The method has been used to study the compatibility between polysorbates and m-cresol in the peptide formulation. It was found that both PS20 and PS80 are compatible with m-cresol (at 2.8 mg/ml) when their levels were not greater than 20 ppm. Significant losses of polysorbates were observed when PS20 and PS80 concentrations were above 50 ppm. Furthermore, the agitation study demonstrated that even trace levels of PS20 and PS80 (e.g., 20 ppm) could stabilize the peptide against fibrillation and aggregation.