Article
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Rapid Determination of Five Residual Solvents in Ursodeoxycholic Acid Raw Materials
Version 1
: Received: 24 October 2023 / Approved: 25 October 2023 / Online: 26 October 2023 (03:38:35 CEST)
A peer-reviewed article of this Preprint also exists.
Zhou, R.; He, J.; Shi, Y.; Gao, X.; Wang, F.; Liu, S. Rapid Determination of Five Residual Solvents in Ursodeoxycholic Acid Raw Materials. Separations 2023, 10, 573. Zhou, R.; He, J.; Shi, Y.; Gao, X.; Wang, F.; Liu, S. Rapid Determination of Five Residual Solvents in Ursodeoxycholic Acid Raw Materials. Separations 2023, 10, 573.
Abstract
The chromatographic conditions were optimized using headspace gas chromatography, and a simple and rapid method was established for the simultaneous determination of five residual solvents in ursodeoxycholic acid raw materials. The corresponding quality standards were revised. The results showed that the concentration of methanol ranged from 0.06mg/ml to 0.3mg/ml, and the concentrations of acetone, tert butanol, ethyl acetate, and triethylamine showed a good linear relationship with the peak area within the range of 0.1mg/ml to 0.5mg/ml (r=0.999); The quantitation limits for methanol, acetone, tert-butanol, ethyl acetate, and triethylamine were 4.2, 0.9, 1.5, 1, and 0.1 μg/ml, respectively, with detection limits of 1.2, 0.25, 0.025, 0.3, and 0.025 μg/ml, respectively. The recovery rates of each solvent ranged from 92.9% to 106.0%, with RSD% (n=9) less than 3.8%; The method exhibited good repeatability, with RSD% (n=6) less than 2.5%. Furthermore, the durability is good. The established method is simple, accurate, specific, and highly sensitive, and can be used for the simultaneous and rapid determination of five residual solvents in ursodeoxycholic acid raw materials.
Keywords
headspace-gas chromatography; ursodeoxycholic acid; residual solvents; triethylamine; tert butanol; ethyl acetate
Subject
Medicine and Pharmacology, Pharmacy
Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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