PK study of octreotide based on LC–MS/MS combining protein precipitation and impurity extraction technique. (April 2015)

• Record Type: Journal Article
• Authors: Wang, Qian; Liang, Yan; Rao, Tai; Xie, Lin; Ye, Wei; Fu, Hanxu; Zhou, Lijun; Xing, Rong; Shao, Yuhao; Xiao, Jingcheng; Kang, Dian; Wang, Guangji
• Is Part Of: Bioanalysis. Volume 7:Number 7(2015)
• Page Start: 885
• Page End: 894
• Publication Date: 2015-04
• Subjects: Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio.15.22
• Languages: English
• ISSNs: 1757-6180

Abstract

Aim: To establish a robust methodology for quantitative analysis of therapeutic peptide in biological samples.Materials & Methods: Octreotide was chosen as a model therapeutic peptide, and oxidized-octreotide was synthesized as internal standard. Protein precipitation combining liquid-liquid extraction technique was adopted to enhance the recovery and reduce the endogenous interferences effectively. A LC–MS/MS method for the quantification of octreotide in plasma has been optimized and validated according to FDA guidelines.Results: Linearity, selectivity, accuracy, precision, stability, matrix effect and recovery were within bioanalytical method validation acceptance criteria as FDA guidelines. The methodology was then successfully applied into the studies for octreotide.Conclusion: This robust methodology would be useful for the PK studies for octreotide and other therapeutic peptides.