Development and validation of an ultra high-performance liquid chromatographic method for the determination of a diastereomeric impurity in (+)-pinoresinol diglucoside chemical reference substance

✍ Scribed by Jing-Zheng Song; Lok Man Cheung; Xin Liu; Chun-Feng Qiao; Yan Zhou; Song-Lin Li; Shi-Lin Chen; Hong-Xi Xu

• Publisher: John Wiley and Sons
• Year: 2010
• Tongue: English
• Weight: 210 KB
• Volume: 33
• Category: Article
• ISSN: 1615-9306
• DOI: 10.1002/jssc.201000053

✦ Synopsis

Abstract

(+)‐Pinoresinol 4,4′‐di‐O‐β__‐D‐glucopyranoside ((+)‐PDG) is one of the major lignans with various pharmacological activities which could be isolated from Duzhong and other plant species. In this study, a diastereomeric impurity, (−)‐pinoresinol 4,4′‐di‐O‐β‐__D‐glucopyranoside ((−)‐PDG), the main impurity was identified in (+)‐PDG chemical reference substance (CRS) and a reliable chromatographic method for rapid purity determination of (+)‐PDG CRS was firstly developed. The optimal chromatographic condition was found to be using ACN/1,4‐dioxane–water (2.5:6:91.5, v/v/v) as mobile phase on a Waters Acquity UPLC HSS T3 column (2.1 mm×100 mm, 1.8 μm) with column temperature of 37°C. The method was validated and applied to determine the chromatographic purity of five (+)‐PDG CRS samples. The content of (−)‐PDG in four commercial (+)‐PDG CRS was 8.47–20.30%, whereas no (−)‐PDG was detected in our in‐house prepared (+)‐PDG CRS in which purity was confirmed to be 99.80%. The above results confirmed that this method is fast and highly efficient for purity determination of the (+)‐PDG CRS.