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DEVELOPMENT AND VALIDATION OF A HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS DETERMINATION OF GLIBENCLAMIDE AND LIPOIC ACID

LUMINIȚA-GEORGETA CONFEDERAT 1#, ALEXANDRA BUJOR 2#, IUSTINA CONDURACHE 3,
LENUȚA PROFIRE 4*, ANCA MIRON 5, NELA BIBIRE 6

1.Department of Microbiology, Faculty of Medicine, “Grigore T. Popa” University of Medicine and Pharmacy, 16 Universității Street, 700115, Iași, Romania
2 .Department of Pharmaceutical Technology, Faculty of Pharmacy, “Grigore T. Popa” University of Medicine and Pharmacy, 16 Universității Street, 700115, Iași, Romania
3 .Department of Biomedical Sciences, Faculty of Medical Bioengineering, “Grigore T. Popa” University of Medicine and
Pharmacy, 16 Universității Street, 700115, Iași, Romania
4 .Department of Pharmaceutical Chemistry, Faculty of Pharmacy, “Grigore T. Popa” University of Medicine and Pharmacy, 16 Universității Street, 700115, Iași, Romania
5 .Department of Pharmacognosy, Faculty of Pharmacy, “Grigore T. Popa” University of Medicine and Pharmacy, 16
Universității Street, 700115, Iași, Romania
6 .Department of Analytical Chemistry, Faculty of Pharmacy, “Grigore T. Popa” University of Medicine and Pharmacy, 16 Universității Street, 700115, Iași, Romania

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Glibenclamide and lipoic acid are drugs frequently co-administered in the treatment of diabetes mellitus, this association targeting the glycaemic control and the management of chronic vascular complications. Considering that literature data do not provide analytical methods for simultaneous determination of these drugs, the aim of this study was to develop and validate a new HPLC method for the achievement of this objective. The developed method allowed the efficient separation of the drugs using acetonitrile and phosphate buffer pH = 2.7 as mobile phase, with gradient elution and UV detection at 201 nm. The method was validated, analysing the following parameters: selectivity, linearity, limit of detection and limit of quantification, precision, accuracy. All the validation parameters were within the specified limits, proving that the HPLC method was selective and linear in the defined concentration range, while the relative standard deviation for the analysis of precision and accuracy was found below ± 2% and ± 5%, respectively. Moreover the method is accessible and could be applied for the simultaneous separation and quantitative determination of the associated drugs in different therapeutic systems.