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

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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)

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

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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

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References

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