Analysis of Metformin and Five Gliptins in Counterfeit Herbal Products: Designs of Experiment Screening and Optimization
| Autor: | Marwa A. Fouad, Ehab F. Elkady, Mohammad Abdul-Azim Mohammad, Wadhah Atef Salem |
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| Rok vydání: | 2021 |
| Předmět: |
Pharmacology
Dipeptidyl-Peptidase IV Inhibitors Isocratic elution Traditional medicine Computer science Sitagliptin Phosphate Saxagliptin Metformin Sitagliptin Phosphate Monohydrate Analytical Chemistry Counterfeit chemistry.chemical_compound Chromatographic separation Drug Counterfeiting chemistry Counterfeit Drugs Phase composition medicine Humans Environmental Chemistry Agronomy and Crop Science Chromatography High Pressure Liquid Food Science medicine.drug |
| Zdroj: | Journal of AOAC INTERNATIONAL. 104:1667-1680 |
| ISSN: | 1944-7922 1060-3271 |
| Popis: | Background Drug counterfeiting is a rising problem due to difficulties with identifying counterfeit drugs and the lack of regulations and legislation in developing countries. Objective This study aims to develop a robust and economic reversed phase high performance liquid chromatography (LC) method for simultaneously determining metformin HCl, vildagliptin, saxagliptin, alogliptin benzoate, sitagliptin phosphate monohydrate, and linagliptin to target counterfeiting. Methods Plackett-Burman (PB) and Box-Behnken (BB) designs were used to screen and optimize the mobile phase composition. Chromatographic separation was carried out on an Inertsil® ODS-3 C18 column with isocratic elution mode and the mobile phase was a mixture of acetonitrile–methanol–ammonium formate buffer, pH 3.5 (25:10:65, v/v/v). This method was applied to analyze synthetic drugs in three traditional Chinese and Indian herbal medicines. To identify the adulterants, thin-layer chromatography (TLC), nuclear magnetic resonance (NMR), and mass spectrometry (MS) were used on counterfeit herbal medicines. Results The developed method is sensitive, simple, rapid, economical, accurate, and highly robust. Student's t-test and variance ratio (F-test at P Conclusion The study found that the analyzed herbal medicines were adulterated with metformin and the quantification of anti-diabetic counterfeits was therefore applied. Highlights This study determined counterfeited anti-diabetic drugs in Indian and Chinese traditional herbal medicines(THMs). Design-of-experiment, PB, and BB designs were used. Method validation was also performed in accordance with the International Conference on Harmonization guidelines. |
| Databáze: | OpenAIRE |
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