Determination of five carbohydrate impurities in amino acid bulk drug by HPLC-ELSD

LIU Lei; JIANG Feng; OUYANG Hanlin; HUI Renjie

doi:10.11665/j.issn.1000-5048.20210109

Journal of China Pharmaceutical University > 2021 > 52(1): 66-70. > DOI: 10.11665/j.issn.1000-5048.20210109

LIU Lei, JIANG Feng, OUYANG Hanlin, HUI Renjie. Determination of five carbohydrate impurities in amino acid bulk drug by HPLC-ELSD[J]. Journal of China Pharmaceutical University, 2021, 52(1): 66-70. DOI: 10.11665/j.issn.1000-5048.20210109

Citation:

PDF (537 KB)

Determination of five carbohydrate impurities in amino acid bulk drug by HPLC-ELSD

School of Pharmaceutical Sciences, Jiangnan University, Wuxi 214122, China

Funds: This study was supported by the Fundamental Research Funds for the Central Universities (No.JUSRP22047) and the Special Funds for Jiangnan University Laboratory Management (No.JDSYS201927)

More Information

Received Date: May 06, 2020
Revised Date: October 14, 2020

Graphical Abstract

Abstract

Abstract

An analytical method was developed for the determination of five carbohydrate impurities in amino acid drug substances by high performance liquid chromatography-evaporative light scattering detection (HPLC-ELSD). Sugar impurities in the amino acid sample were separated and enriched by cation exchange resin. A Lichropher NH₂ column (4.6 mm × 250 mm, 5 μm) was used for chromatographic separation, and a gradient elution was performed using acetonitrile-water as mobile phase. The drift tube temperature was 40 ^oC, the gain value was 8, and nitrogen (350 kPa) was auxiliary gas. Method validation results showed that the limits of detection for fructose, glucose, sucrose, maltose and lactose were in the range of 20.8-75.0 mg/kg and that the limits of quantitation were in the range of 96.2-238.8 mg/kg. Good linear relationship (r ≥ 0.999) were in the linear range for the five sugars, and the recoveries ranged from 84.9%-107.8%. With easy operation, high sensitivity, good precision and reliable accuracy, the method can be used for analysis of residual sugar impurities in amino acid drug bulk drug.
- amino acids,
- sugar impurities,
- HPLC-ELSD,
- cation exchange resin

FullText(HTML)

References (16)

References

[1]	. J Immunol， 2017， 198（5）： 1900-1909.
[2]	Hashimoto SI. Discovery and history of amino acid fermentation［J］. Adv Biochem Eng Biotechnol， 2017， 159： 15-34.
[3]	Szilágyi TG， Vecseri BH， Kiss Z， et al. Analysis of the oligosaccharide composition in wort samples by capillary electrophoresis with laser induced fluorescence detection［J］. Food Chem， 2018， 256： 129-132.
[4]	Fa Y， Liu YH， Xu AH， et al. Color and alcohol removal for the simultaneous detection of amino acids and sugars in wine by two-dimensional ion chromatography［J］. J Chromatogr B， 2017， 1063： 36-41.
[5]	Li B， Lu F， Tian SY. Simultaneous determination of neutral sugar， uronic acid， amino sugar and sialic acid of polysaccharides by gas chromatography［J］. Food Ferment Ind （食品与发酵工业）， 2011， 37（9）： 208-211.
[6]	Nayik GA， Dar BN， Nanda V. Physico-chemical， rheological and sugar profile of different unifloral honeys from Kashmir valley of India［J］. Arab J Chem， 2019， 12（8）： 3151-3162.
[7]	Chen JC， Li L， Zhou X， et al. Preliminary characterization and antioxidant and hypoglycemic activities in vivo of polysaccharides from Huidouba［J］. Food Funct， 2018， 9（12）： 6337-6348.
[8]	Georgelis N， Fencil K， Richael CM. Validation of a rapid and sensitive HPLC/MS method for measuring sucrose， fructose and glucose in plant tissues［J］. Food Chem， 2018， 262： 191-198.
[9]	Ai YJ， Yu Z， Chen YQ， et al. Rapid determination of the monosaccharide composition and contents in tea polysaccharides from Yingshuang Green Tea by pre-column derivatization HPLC［J］. J Chem， 2016， 2016： 1-5.
[10]	Beňo E， Góra R， Hutta M. Development of a precolumn derivatization HPLC method with diode-array detection for the determination of amino sugars in peat and soil humic acids［J］. J Sep Sci， 2018， 41（4）： 814-821.
[11]	Gao Q， Han ZT. Determination of soluble sugars in forest biomass raw materials by high performance liquid chromatography-differential refractive index detector［J］. Chin J Anal Lab（分析试验室）， 2017， 36（12）： 1406-1410.
[12]	Wang XJ， Zhang YL， Liu JB， et al. Analysis of glycosyls profile of aroma glycosides in Meili Grape by high performance liquid chromatography-refractive index detector with amino column ［J］. Chin J Anal Chem（分析化学）， 2017， 45（5）： 681-686.
[13]	Ma CM， Sun Z， Chen CB， et al. Simultaneous separation and determination of fructose， sorbitol， glucose and sucrose in fruits by HPLC-ELSD［J］. Food Chem， 2014， 145： 784-788.
[14]	Ding HL， Li C， Jin P， et al. Simultaneous determination of monosaccharides， disaccharides oligosaccharides and sugar alcohols in foods by high performance liquid chromatography with evaporative light-scattering detection［J］. Chin J Chromatogr（色谱）， 2013， 31（8）： 804-808.
[15]	Lindqvist DN， Pedersen H?， Rasmussen LH. A novel technique for determination of the fructose， glucose and sucrose distribution in nectar from orchids by HPLC-ELSD［J］. J Chromatogr B， 2018， 1081： 126-130.
[16]	Tian Y， Chen ZX， Zhang N， et al. Study on the method of reducing sugar derivatization in water-extract of Chinese materia medica［J］. Chin J Tradit Chin Med Pharm（中华中医药杂志）， 2016， 31（9）： 3803-3807.

Cited By

Cited by

Periodical cited type(3)

1.	龚琳琳. 来曲唑原料药的含量测定及有机杂质分析. 化学与粘合. 2024(03): 317-321 .
2.	房思萌，隋玉荣，韩晓捷. 药用辅料山梨醇中还原糖控制分析的研究进展. 现代药物与临床. 2023(02): 478-482 .
3.	吴会斌，武小冬. Clinimix E（克灵麦）中4-胍基丁酸的测定. 辽宁化工. 2022(02): 281-284 .

Other cited types(1)

Get Citation

PDF

XML

Article views (355) PDF downloads (645) Cited by(4)

Turn off MathJax

Article Contents

Abstract

References

Determination of five carbohydrate impurities in amino acid bulk drug by HPLC-ELSD

Abstract

References

Cited by

Periodical cited type(3)

Other cited types(1)

Catalog

Export File

Citation

Format

Content