Method validation of calycosin-7-O-β-D-glucoside in “Astragalus mongholicus” injection by High-performance liquid chromatography
- VernacularTitle:“Монгол хунчир” тарилгын эмэнд каликозин-7-O-β-D-гликозид тодорхойлох өндөр идэвхт шингэний хроматографийн аргын баталгаажилт
- Author:
Tsendbadam B
1
;
Battulga B
2
;
Lkhaasuren L
2
;
Baljinnyam I
1
;
Tsetsegmaa S
2
;
Khurelbaatar L
2
;
Munkhtsetseg R
1
Author Information
1. Tsombo Pharma Co., LTD, Ulaanbaatar, 18072-0021, Mongolia
2. Drug research insitute, Ulaanbaatar, 14250, Mongolia
- Publication Type:Journal Article
- Keywords:
injection;
Method validation;
Astragalus,
- From:Mongolian Medical Sciences
2021;195(1):43-50
- CountryMongolia
- Language:Mongolian
-
Abstract:
Introduction:Calycosin-7-O-β-D-glucoside is a glycosyloxyisoflavone that is calycosin substituted by a beta-D-glucopyranosyl residue at position at 7 via a glycosidic linkage. calycosin-7-O-β-D-glucoside, a
calycosin derivative compound derived from Astragali Radix, has protective effect against ischemia/
reperfusion injury as well as bacterial endotoxin-induced vascular cell injury. A joint research team of
the “Tsombo Pharm” Co., LTD and the Drug research Institute is conducting an experiment to produce
a solution of “Astragalus mongholicus” injection prepared by Astragalus mongholicus bunge.
Goal :The aim of this study was to develop the validation method of Calycosin-7-O-β-D-glucoside in
“Astragalus mongholicus” injection.
Material and Methods:As a test sample “Astragalus mongholicus” injection was produced by “Tsombo pharma” Co., LTD.
The starndard Calycosin-7-O-β-D-glucoside was supplied from Xilong Scientific Co., Ltd. The reagent
were high-performance liquid chromatography (HPLC) grade acetonitrile, formic acid, methanol and
purified water. Shimadzu HPLC (CMB-20 A, UV detector Shimadzu SPD-20A was used as the
analytical instrument and the analysis conditions were as follows Table 1.
Results:The calibration curves for Calycosin-7-O-β-D-glucoside were made by plotting the peak area versus
the concentration for each analyte using regression analysis. Each calibration curve was obtained
using six levels of concentrations in the range 12.5-100µg/ml. The linear correlation coefficient (R2)
for all calibration curves was higher than 0.9981 for all analytes. The limit of detection and limit of
quantitation for Calycosin-7-O-β-D-glucoside were in 10.37 µg/ml and 31.45 µg/ml. Accuracy and
precision were assessed by analyzing five sets of samples, independently prepared at low (50%)
middle (100%) and high (150%) concentrations. The RSD values of both repeatability and intermediate precision were below 0.68% and 0.618% the accuracy remaining between 95.55 to 101.71%. The
resulting accuracy data were satisfactory for the quantitative analysis of Calycosin-7-O-β-D-glucoside
in “Astragalus mongholicus” injection.
Conclusions:Finally, this method can be employed conveniently, reliably and successfully for the estimation
of Calycosin-7-O-β-D-glucoside for routine quality contral and stability studies in “Astragalus
mongholicus” injection.
- Full text:2021-195(1)-43-50.pdf
