Development of a method for the quantitative determination of glibenclamide in tablets

Authors

DOI:

https://doi.org/10.14739/2409-2932.2023.2.274336

Keywords:

glibenclamide, 2,3-dichloro-1,4-naphthoquinone, spectrophotometry, validation study, quantitative determination, pharmaceutical preparations, substance, State Pharmacopoeia of Ukraine (SPU)

Abstract

Aim. To develop and validate a spectrophotometric technique for quantitative determination of glibenclamide in tablets by reaction with 2,3-dichloro-1,4-naphthoquinone.

Materials and methods. In the study, the substance glibenclamide of pharmacopoeial purity was used, tablets – “Maninil” 5 mg and “Glibenclamid-Zdorovye” 5 mg, 2,3-dichloro-1,4-naphthoquinone of the “CFA” qualification was chosen as a reagent, as a solvent – dimethylformamide (DMF) “CFA”.

The following analytical equipment was used for the research: spectrophotometer “Specord-200” (Analytic Jena AG, Germany), water bath “MEMMERT WNB7”, laboratory electronic scales RADWAG XA 210. 4Y, measuring laboratory vessels of class A.

Results. A new, simple spectrophotometric method of quantitative determination of glibenclamide in tablets by reaction with 2,3-dichloro-1,4-naphthoquinone in DMF medium was developed. The absorption maximum was at 489–491 nm. The value of the detection limit is 10.9 μg/ml, which indicates sufficient sensitivity of the reaction.

Subordination to the basic law of light absorption is within the limits of concentrations of 13.7–27.4 mg/100 ml. In the process of developing the methodology, the following validation characteristics were determined: specificity, linearity, precision, correctness, and robustness.

Conclusions. The methodology for the quantitative determination of glibenclamide was developed and validated according to the requirements of the State Pharmacopoeia of Ukraine. It has been proven that the method is simple, accessible, and validated for such characteristics as linearity, convergence and robustness and can be used for application in laboratories for quality control of medicinal products.

Author Biographies

L. H. Leleka, Zaporizhzhia State Medical and Pharmaceutical University, Ukraine

Postgraduate student of the Department of Analytical Chemistry

S. O. Vasuik, Zaporizhzhia State Medical and Pharmaceutical University, Ukraine

PhD, DSc Professor, Head of the Department оf Analytical Chemistry

References

International Diabetes Federation. (2021). IDF Diabetes Atlas 10th ed. https://diabetesatlas.org

State Enterprise Ukrainian Scientific Pharmacopoeial Center of Medicines Quality. (2015). Derzhavna Farmakopeya Ukrayiny [The State Pharmacopoeia of Ukraine (Vol. 1, 2nd ed.)]. Kharkiv: State Enterprise Ukrainian Scientific Pharmacopoeial Center of Medicines Quality. [in Ukrainian].

Andayani, R., Pitasari, F., & Rusdi. (2015). Development and validation of TLC densitometry method for simultaneous determination of metformin HCl and glibenclamide in tablets dosage form. Journal of Chemical and Pharmaceutical Research, 7(9), 159-164.

Bhende, S. D., Varanasi, M. B., & Abbulu, K. (2020). A Sensitive HPTLC Method for the Estimation of Glibenclamide, Rosiglitazone Maleate and Metformin Hydrochloride from a Multicomponent Dosage Form. Journal of chromatographic science, 58(5), 418-426. https://doi.org/10.1093/chromsci/bmz124

Elkady, E. F., El-Zaher, A. A., Elwy, M. H., & Saleh, M. A. (2015). Validated Liquid Chromatographic Method for Simultaneous Determination of Metformin, Pioglitazone, Sitagliptin, Repaglinide, Glibenclamide and Gliclazide - Application for Counterfeit Drug Analysis. Journal of Analytical & Bioanalytical Techniques, (S13). https://doi.org/10.4172/2155-9872.s13-007

Havele, S., & Dhaneshwar, S. (2014). Determination of glibenclamide, metformin hydrochloride and rosiglitazone maleate by reversed phase liquid chromatographic technique in tablet dosage form. Chemical Industry and Chemical Engineering Quarterly, 20(1), 39-47. https://doi.org/10.2298/ciceq120607101h

Alam, M. A., Al-Jenoobi, F. I., & Al-Mohizea, A. M. (2018). Rapid, Validated UPLC-MS/MS Method for Determination of Glibenclamide in Rat Plasma. International Journal of Analytical Chemistry, 2018. https://doi.org/10.1155/2018/2569027

Zhang, Y. F., Liu, X. Q., Wang, Y., Xu, X., Zhong, M. K., Zhang, P., & Ma, C. L. (2021). Development and validation of an ultra-high performance liquid chromatography with tandem mass spectrometry method for the simultaneous quantification of direct oral anticoagulants in human plasma. Journal of chromatography. B, Analytical technologies in the biomedical and life sciences, 1182, 122952. https://doi.org/10.1016/j.jchromb.2021.122952

Confederat, L. G., Bujor, A., Condurache, I., Profire, L., Miron, A., & Bibire, N. (2021). Development and validation of a high performance liquid chromatography method for simultaneous determination of glibenclamide and lipoic acid. Farmacia, 69(2), 246-252. https://doi.org/10.31925/farmacia.2021.2.8

R. Tengli, A. (2013). Method Development and Validation of Metformine, Pioglitazone and Glibenclamide in Tablet Dosage Form by using RP-HPLC. Biochemistry & Analytical Biochemistry, 02(02). https://doi.org/10.4172/2161-1009.1000130

Haq, N., Alanazi, F. K., Alsarra, I. A., & Shakeel, F. (2014). Rapid Analysis of Glibenclamide Using an Environmentally Benign Stability-Indicating RP-HPLC Method. Iranian journal of pharmaceutical research : IJPR, 13(3), 863-872.

Alhemiary, N. A. F. (2014). Derivative spectrophotometric and HPLC validated methods for simultaneous determination of metformin and glibenclamide in combined dosage form. Oriental Journal of Chemistry, 30(4), 1507-1516. https://doi.org/10.13005/ojc/300408

Porwal, P. K., & Talele, G. S. (2017). Development of validated HPLC-UV method for simultaneous determination of Metformin, Amlodipine, Glibenclamide and Atorvastatin in human plasma and application to protein binding studies. Bulletin of Faculty of Pharmacy, Cairo University, 55(1), 129-139. https://doi.org/10.1016/j.bfopcu.2016.10.002

Sohrabi, M. R., Kamali, N., & Khakpour, M. (2011). Simultaneous spectrophotometric determination of metformin hydrochloride and glibenclamide in binary mixtures using combined discrete and continuous wavelet transforms. Analytical sciences, 27(10), 1037-1041. https://doi.org/10.2116/analsci.27.1037

Gloria, N., & Pius, U. (2018). Spectrophotometric and thermodynamic determination of glibenclamide using 2,3-dichloro-5,6-dicyano-1,4-benzoquinone. Der pharma chemica, 10(3), 9-15.

Antakli, S., Nejem, L., & Alraii, M. (2021). Determination of Glibenclamide By Analytical Spectrophotometry. Journal of advances in chemistry, 18, 40-48. https://doi.org/10.24297/jac.v18i.8963

Patil, S. S., & Bonde, C. G. (2009). Development and validation of analytical method for simultaneous estimation of glibenclamide and metformin HCl in bulk and tablets using UV - Visible spectroscopy. International Journal of ChemTech Research, 1(4), 905-909.

Grizodub, A. I. (2016). Standartyzovani protsedury validatsii metodyk kontroliu yakosti likarskykh zasobiv [Standardization of the procedure for validation of methods of quality control of drugs]. State Enterprise "Ukrainian Scientific Pharmacopoeial Center for Drug Quality". [in Ukrainian].

Downloads

Published

2023-07-03

How to Cite

1.
Leleka LH, Vasuik SO. Development of a method for the quantitative determination of glibenclamide in tablets. Current issues in pharmacy and medicine: science and practice [Internet]. 2023Jul.3 [cited 2024May24];16(2):135-40. Available from: http://pharmed.zsmu.edu.ua/article/view/274336

Issue

Section

Original research