High performance liquid chromatograohy method for determination of alkaloid, method validation in Norbu-7 granule
- VernacularTitle:Норов 7 мөхлөг эмэнд алкалоид тодорхойлох өндөр идэвхт шингэний хроматографийн арга, аргын баталгаажилт
- Author:
Sugarmaa B
1
;
Battulga B
1
;
Lkhaasuren R
1
;
Badamtsetseg S
1
;
Tsetsegmaa S
1
;
Khurelbaatar L
2
Author Information
1. Drug Research Institute
2. Monos Group
- Publication Type:Journal Article
- Keywords:
Matrine;
Oxymatrine;
Sophora flavescens;
Traditional medicine
- From:Mongolian Medical Sciences
2021;195(1):64-69
- CountryMongolia
- Language:Mongolian
-
Abstract:
Introduction :The roots of Sophora Flavescentis is one of the key ingredient in Norbu 7 traditional medicine, the
bioactive compound being quinolizidine alkaloids, matrine and oxymatrine. A high performance liquid
chromatography (HPLC) method was used to determine matrine, oxymatrine simultaneously in the
traditional medicine. The HPLC method was tested and validated for selective determination of matrine
and oxymatrine in the Norbu 7 granule. The proposed method was validated for linearity, precision
(system precision, method precision, intermediate or inter- day precision) and accuracy, stability in
analytical solution, system suitability and ruggedness.
Goal:The goal of this study was to develop validated determination method of alkaloid in Norbu 7 granule
for quality control.
Material and Method:HPLC analysis was performed on Chromecore amino bonded silica gel as the stationary phase (250
mm : 4.6 mm i.d., 5µm) using mixture of acetonitrile, dehydrated ethanol and 3% phosphoric acid
(80:10:10) as the mobile phase, 220 nm as the UV light detection.
The research methodology was approved by Research Ethic Review Committee of Mongolian
University of Pharmaceutical Science on 16th of November, 2020.
Results:The calibration curve of oxymatrine showed good linearity (R2=0.9955) within the established range
of 8 – 64 µg/ml. The limit of detection (LOD) and quantification (LOQ) were 10.13 µg/ml and 30.71 µg/
ml respectively. Good results were achieved with repeatability (%RSD < 2.0) and recovery (93.08 –
104.32%).
Conclusion:The method was found to be selective, accurate, reproducible and the other components did not
interfere with determinations. It was successfully used to analyze the granule traditional medicine with
7 different plant formulation and additives. The HPLC method can be used to evaluate and control
quality, stability of Norbu 7 granules.
- Full text:2021-195(1)-64-69.pdf
