Development and validation of an ultra high-performance liquid chromatographic method for the determination of a diastereomeric impurity in (+)-pinoresinol diglucoside chemical reference substance.
(+)-Pinoresinol 4,4'-di-O-beta-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-beta-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 x 100 mm, 1.8 microm) with column temperature of 37 degrees 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.
Song
Jing-Zheng
JZ
Chinese Medicine Laboratory, Hong Kong Jockey Club Institute of Chinese Medicine, Shatin, N. T., Hong Kong, P. R. China.
Cheung
Lok Man
LM
Liu
Xin
X
Qiao
Chun-Feng
CF
Zhou
Yan
Y
Li
Song-Lin
SL
Chen
Shi-Lin
SL
Xu
Hong-Xi
HX
D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000592:standards; D004340:Drug Contamination; D017705:Lignans / Q000032:analysis* / Q000737:chemistry*; D015394:Molecular Structure; D013237:Stereoisomerism
D017705:Lignans; C013200:pinoresinol diglucoside