Determination of Related Substances in 20(S)-Protopanaxadiol Bulk Drug by HPLC
10.13748/j.cnki.issn1007-7693.20223919
- VernacularTitle:HPLC测定20(S)-原人参二醇原料药中有关物质
- Author:
WANG Jingmin
1
;
FU Xinzhen
1
;
QU Guiwu
1
;
KOU Lijuan
1
;
GUO Lin
1
;
ZHANG Shumin
1
;
LIU Ke
2
;
XIE Zeping
1
Author Information
1. School of Pharmacy, Binzhou Medical University, Yantai 264003, China
2. Shandong Boyuan Biomedical Research Co., Ltd., Yantai 264670, China
- Publication Type:Journal Article
- Keywords:
HPLC;
20(S)-protopanaxadiol;
bulk drug;
content determination;
related substances
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(18):2562-2568
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To establish a high-performance liquid chromatographic method for the detection of 10 related substances in 20(S)-protopanaxadiol bulk drug. METHODS Used an ACQUITY UPLC BEH C18 chromatographic column with ultrapure water(A)-acetonitrile(B) as mobile phase. The flow rate was 0.20-0.25 mL·min-1, the detection wavelength was set at 203 nm, the column temperature was maintained at 35℃, and the injection volume was 5 μL. RESULTS 20(S)-protopanaxadiol and various impurities had reached an effective separation with a good linear relationship; the sample recovery(n=9) was ranging from 94.8% to 102.2%. The RSD values were <2.0%; the intra-day and inter-day precision RSD values were<2.0%, with a good precision; the related substances C, F, H, and I were stable in solution with RSD values<2.0% in 48 h at the room temperature; while impurities A, B, D, E, G and J were unstable under the same condition with RSD>2.0%. CONCLUSION The method is simple, sensitive and accurate, which can simultaneously determine 10 related substances in API 20(S)-protopanaxadiol, which can effectively identify the relevant substances in API and provide reference for the improvement of its production process and quality control.
