Method Validation of Dihydromyricetin in Anti-hangover preparation by High Performance Liquid Chromatography
- VernacularTitle:Шарталтын эсрэг бэлдмэлд дигидромерицетин тодорхойлох өндөр идэвхт шингэний хроматографийн аргын баталгаажилт
- Author:
Battulga B
1
;
Badamtsetseg S
1
;
Bayanmunkh A
1
;
Tsetsegmaa S
1
;
Lkhagva L
1
;
Khurelbaatar L
1
Author Information
1. Drug Research Institute
- Publication Type:Journal Article
- Keywords:
Dihydromyricetin;
High performance liquid chromatography;
anti-hangover preparation;
method validation
- From:Mongolian Medical Sciences
2019;189(3):54-61
- CountryMongolia
- Language:Mongolian
-
Abstract:
Background:The high performance liquid chromatography (HPLC) method was developed for selective determination
of dihydromyricetin in capsule formulation dietary supplement containing other components. Further, 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.
The developed method exhibited the best results in terms of the aforesaid validation parameters. The
other components and additives did not interfere in their determinations. The method was found to be
selective, simple, economical, accurate, reproducible, rapid and reliable for routine estimation purpose of
dihydromyricetin in dietary supplement capsule.
Goal :The goal of this study was to develop the validation method of dihydromyricetin in the dietary supplement.
Material and Methods :The hangover preparation was produced by Technological section of Drug Research Institute. The
standard dihydromyricetin was supplied from Sigma Aldrich Co. We used solvents for HPLC grade
(methanol, acetonitrile). Chromatographic conditions: A gradient HPLC (Shimadzu LC20AD) with serial
dual plunger pump; analytical column: Supelco inertsil С18 250 × 4.6 mm, particle size 5 μm; flow rate: 1
ml/min; column temperature: 350C, detection: UV 365 nm. Chromatographic procedure: 20 μl of the mixed standard preparation and assay (sample) preparation were separately injected into the chromatography, the chromatograms were recorded, and the responses for the major peaks were measured. The run time
was approximately 10 minutes.
Results :The calibration curves for dihydromyricetin 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 28-224 µg/mL. The linear correlation coefficient (r2 ) for all calibration curves was higher than 0.999 for all analytes. The LOD and LOQ for dihydromyricetin were in 11.29 µg/mL and 34.21 µg/mL, respectively. Accuracy and precision were assessed by analyzing five sets of samples, independently prepared at low, middle and high concentrations. The RSD values of both repeatability and intermediate precision were below 0.261% and 0.262%. The accuracy remaining between 101.65 to 104.7%. The resulting accuracy data were satisfactory for the quantitative analysis of dihydromyricetin in anti-hangover preparation. The results of summarized in Table 1, 2, 3. This article presents a simple, accurate, reproducible, and thoroughly validated HPLC-based method for qualitative and quantitative analysis of dihydromyricetin, as part of the quality assessment of products containing anti-hangover preparation.
- Full text:2019-189(3)-54-61.pdf
