Abstract
Background: The Salbutamol sample in tablets which contains a mixture of 2 enantiomers including R-salbutamol (Levosalbutamol) and S-Salbutamol (Dextrosalbutamol), as usal it forms racemate on the market. When using normal electrophoretic conditions, this racemic mixture only forms 01 peak on the electrophoretic chart. It is necessary to find conditions, in especially, using chiral selective agents, to separate the enantiomers of Salbutamol. This work was conducted with two objectives: 1) To develop a method to separate the enantiomers of salbutamol by capillary electrophoresis. 2) To validate the researched method.
Materials and methods: Materials: Salbutamol in tablets. Methods: After optimizing the process to separate the enantiomers of salbutamol by capillary electrophoresis, the method was validated according to ICH and AOAC guidelines and applying the method to analyze samples.
Results: Electrophoresis conditions: Fused-silica capillary column (effective column length: 44 cm, total column length 52,5 cm, internal diameter: 50 µm), background electrolyte (BGE): Tris 60 mM at pH 1, voltage: +20 kV, column temperature: 25 oC, chiral selective agent: methyl-b-cyclodextrin 250mg/ml. The method was validated and met ICH and AOAC requirements.
Conclusion: The method with high precision and selectivity, excellent detection limit was used to separate the enantiomers of salbutamol in tablets.
| Published | 2025-09-30 | |
| Fulltext |
|
|
| Language |
|
|
| Issue | Vol. 15 No. 5 (2025) | |
| Section | Original Articles | |
| DOI | 10.34071/jmp.2025.5.23 | |
| Keywords | Salbutamol, điện di mao quản, , methyl-b-cyclodextrin, Levosalbutamol, Dextrosalbutamol salbutamol, capillary electrophoresis, methyl-b-cyclodextrin, Levosalbutamol, Dextrosalbutamol |
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Copyright (c) 2025 Hue Journal of Medicine and Pharmacy
Rentsch KM. The importance of stereoselective determination of drugs in the clinical laboratory. J Biochem Biophys Methods. 2002 Dec 31; 54(1-3): 1-9.
Sulaiman K, Mari-Luiza K, Gerhard KES. Advances of capillary electrophoresis enantioseperations in pharmaceutical analysis (2017-2020). Electrophoresis. 2021Sep; 42(17-18), 1709-1725.
Niall S. Salbutamol: hero or villain?. Paediatrics and Child Health. 2023 April; 33(4), 97-103.
Bộ Y tế. Dược điển Việt Nam V. NXB Y học, Hà Nội. 2018.
Fanali S. Capillary Electrophoresis in Chiral Analysis, Bezhan Chankretadze, John Wiley & Sons, Chichester, UK. 1997, ISBN 0-471-974 15-3, 1998: 572.
ICH Secretariat. Validation of Analytical Procedures: Text and methodology. International conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. 2005, pp. 1 - 17.
Association of official analytical chemists (AOAC). Guidelines for Standard Method Performance Requirements. 2016.
Ela E, Carmen G, García A, Maria LM. Rapid determination of salbutamol in pharmaceutical preparations by chiral capillary electrophoresis. Electrophoresis. 2003 Aug; 24(15), 2680-2686.
Yan K, Zhang H, Hui W, Zhu H, Li X, Zhong F, Tong X, Chen C. Rapid screening of toxic salbutamol, ractopamine, and clenbuterol in pork sample by high-performance liquid chromatography-UV method. Journal of Food Drug Analysis. 2016 April; 24(2): 277-283.
Esquisabel AHR, Gascon AR, Igartua M, Calvo B, Pedraz JL. Determination of salbutamol enantiomers by high-performance capillary electrophoresis and its application to dissolution assays. Journal Pharm Biomed Analysis. 1997 Oct; 16(2): 357-366.
Rogan MM, Altria KD, Goodall DM. Enantiomeric separation of salbutamol and related impurties using capillary electrophoresis. Electrophoresis. 1994 Jun; 15(6): 808-817.