Method validation of hydroxysafflor yellow A in “Carthamus tinctorius” injection by High-performance liquid chromatography
- VernacularTitle:“Гүргэм” тарилгын эмэнд гидроксисафлор шар А тодорхойлох өндөр идэвхт шингэний хроматографийн аргын баталгаажилт
- Author:
Baljinnyam I
1
;
Tsendbadam B
1
;
Battulga B
2
;
Munkhtsetseg R
1
;
Badamtsetseg S
2
;
Bayanmunkh A
2
;
Tsetsegmaa S
2
;
Lkhaasuren R
2
Author Information
1. Tsombo Pharma Co., LTD
2. Drug Research Institute
- Publication Type:Journal Article
- Keywords:
Safflower;
injection;
flavonaid;
carthami
- From:Mongolian Medical Sciences
2021;195(1):56-63
- CountryMongolia
- Language:Mongolian
-
Abstract:
Introduction:Carthamus tinctorius L. widely accepted as Safflower or false saffron, belongs to the Compositae
or Asteraceae family. Hydroxysafflor yellow A is the main active chemical compound present in
florets of Carthamus tinctorius L. A joint research team of the “Tsombo Pharm” Co., LTD and the
Drug research Institute is conducting an experiment to produce a solution of “Carthamus tinctorius”
injection prepared by Carthamus tinctorius L.
Goal :The aim of this study was to develop the validation method of hydroxysafflor yellow A in “Carthamus
tinctorius” injection.
Material and Methods :As a test sample “Carthamus tinctorius” injection was produced by “Tsombo pharma” Co., LTD. The
standard Hydroxysafflor yellow A was supplied from Sigma-Aldrich Co., Ltd. The reagent were high-performance liquid chromatography grade acetonitrile, phosphoric 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:A Shimpack С18 column was used with methanol:acetonitrile:0.7% phosphoric acid as the mobile
phase under the condition of gradient elution. The hydroxysafflor yellow A were analyzed by using
a timed wavelength measure according to their maximum absorption wavelength. Accuracy and
precision were assessed by analyzing five sets of samples, independently prepared at low (50%)
middle (100%) and high (150%) concentrations. The intraday and interday precisions of the
investigated compound were less than 1.59 % and the average recoveries ranged from 81.9% to
101.5%.
There were good linear correlations between the concentrations of the hydroxysafflor yellow A and
its chromatographic peak areas (R2 = 0.998), the proposed method was successfully applied to
determine the hydroxysafflor yellow A in “Carthamus tinctorius” injection.
Conclusions:The results indicated that the proposed method is simple, stable, and accurate and could be readily
utilized as a quality control method for manufacturing process of “Carthamus tinctorius” injection.
- Full text:2021-195(1)-56-63.pdf
