Research Article
Analysis and Preparation of Linaclotide by High Performance Liquid Chromatography
Yi-Shen Zhu*, Tao Feng, Yong-Qin Diao and Chun-Yan TuCollege of Biotechnology and Pharmaceutical Engineering, Nanjing Tech University, Nanjing 211816, China
- *Corresponding Author:
- Yi-Shen Zhu
College of Biotechnology and Pharmaceutical Engineering
Nanjing Tech University
Nanjing 211816, China
Tel: +8618900660563
Fax: +862558139910
E-mail: zhuyish@njtech.edu.cn
Received date: June 03, 2017; Accepted date: June 09, 2017; Published date: June 12, 2017
Citation: Zhu YS, Feng T, Diao YQ, Tu CY (2017) Analysis and Preparation of Linaclotide by High Performance Liquid Chromatography. J Anal Bioanal Tech 8:366. doi: 10.4172/2155-9872.1000366
Copyright: © 2017 Zhu YS, 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.
Abstract
Linaclotide, a synthetic peptide, is a guanylate cyclase-C (GC-C) agonist for treating irritable bowel syndrome with constipation and chronic idiopathic constipation. A simple, precise and selective RP-HPLC method for linaclotide was developed and validated. Analysis was achieved with a SinoChrom ODS-BP column, mobile phase A and B comprised 30 mol·L-1 phosphate (pH 2.8) solution and acetonitrile respectively, gradient elution B% set to 7%?25% from 0 to 32 min and to 25% from 32 to 50 min, flow rate of 1.0 mL·min-1, oven temperature at 40?, injection volume of 20 µL, and UV detection wavelength at 214 nm. Method validation was carried out in linearity, LOD, LOQ, precision and stability. Modified method for linaclotide preparation on a preparative liquid chromatography was developed from the analytical method and applied successfully.
