Spectrophotometric Uv-Vis Analysis of Glimepiride dan Metformin HCl in Combined Tablet Dosage Form Using Mean Centering ofRatio Spectra (MCR) Method
DOI:
https://doi.org/10.35451/jfm.v9i1.3884Keywords:
Glimepirid, Metformin HCl, MCR, SpektrofotometriAbstract
Introduction: Antidiabetic drugs available on the market frequently used in combination, where multiple active ingredients with distinct advantages are combined into a single tablet formulation to achieve maximum antidiabetic efficacy. Objective: This study aimed to perform simultaneous quantification of glimepride and metformin HCl in combined tablet formulation without prior separation using UV Spectrophotometry via the Mean Centering of Ratio Spectra (MCR) method and using acetonitryl-buffer pH 4.0 1:1 as solvent. Methods: The study was conducted by first obtaining ratio spectra derived from dividing the absorbance spectra by their respective component divisors. The result amplitude values were then used to construct regression equation for determining the drug content in tablet formulation. Result: The result showed that the content of glimepiride and metformin HCl were (97.70 ± 0.34) % and (103.98 ± 1.71) % respectively. The validation results showed R2 values (0.999; 0.998), Accuracy (101.76%; 100.99%), Precision (0,76%; 0,43%), LOD (0,395; 0,314) and LOQ (1,199; 0,9531) respectively. Conclusion: Based on the findings, it is concluded that the simultaneous analysis of glimepiride and metformin HCl in combined tablet formulation can be achieved using MCR method with acetonitryl-buffer pH 4.0 1:1 as solvent and meets validation requirements.
Downloads
References
[1] Diabetes [Internet]. [cited 2026 Aug 5]. Available from: https://www.who.int/news-room/fact-sheets/detail/diabetes
[2] Lim PC, Chong CP. What’s next after metformin? focus on sulphonylurea: add-on or combination therapy. Pharm Pract (Granada). 2015 Sep 30;13(3):606–606. doi:10.18549/PharmPract.2015.03.606
[3] Komarudin DK S Farm, Dewi D apt MAD S Si, M.Farm apt SMY, M.Si apt CRM, M.Si SMT S Farm, M.Si EM S Pd, et al. Analisis Farmasi: Prinsip, Metode, dan Aplikasi Bahan Obat dan Sediaan. PT Bukuloka Literasi Bangsa; 2025. 168 p.
[4] Waraich HS, Kaur A. Comparative Efficacy and Safety of Glimepiride-Metformin and Glibenclamide-Metformin Combinations for Uncontrolled Type 2 Diabetes: A Randomized Controlled Trial. IJLBPR. 2024 Jun 15;13(6):233–8. doi:10.69605/ijlbpr_13.6.43
[5] Lv Z, Guo Y. Metformin and Its Benefits for Various Diseases. Front Endocrinol. 2020 Apr 16;11. doi:10.3389/fendo.2020.00191
[6] Sher N, Fatima N, Perveen S, Siddiqui FA. Simultaneous determination of anti-diabetic drugs. Braz J Pharm Sci. 2019;55:e17394. doi:https://doi.org/10.1590/s2175-97902019000217394
[7] Fachi MM, Cerqueira LB, Leonart LP, Francisco TMGD, Pontarolo R. Simultaneous Quantification of Antidiabetic Agents in Human Plasma by a UPLC–QToF-MS Method. Koomen JM, editor. PLoS ONE. 2016 Dec 8;11(12):e0167107. doi:10.1371/journal.pone.0167107
[8] Ayman M. Mohsen, Hayam M. Lotfy, Amr M. Badawey, Hesham Salem, Sonia Z. Elkhateeb. Application of three novel spectrophotometric methods manipulating ratio spectra for resolving a pharmaceutical mixture of chlorphenoxamine hydrochloride and caffeine. international Journal of Pharmacy and Pharmaceutical Sciences. 2013;5.
[9] Mohseni N, Bahram M. Mean centering of ratio spectra for colorimetric determination of morphine and codeine in pharmaceuticals and biological samples using melamine modified gold nanoparticles. Anal Methods. 2016;8(37):6739–47. doi:10.1039/C6AY02091G
[10] Nejem RM, Issa MM, Shanab AA, Shaat NT. Double divisor mean centering of ratio spectra as a developed spectrophotometric method for the analysis of five-component mixture in drug analysis. J Saudi Chem Soc. 2017 Jan 1;21(1):S283–92. doi:10.1016/j.jscs.2014.03.001
[11] Tarigan RE, Silitonga AS, Sari M, Nadia S. Development and validation of mean centering ratio spectra spectrophotometry method for binary mixture of glimepiride and metformin hydrochloride in tablet disage form. In. Belgorod, Russia; 2023 [cited 2026 Sep 3]. p. 150005. Available from: http://aip.scitation.org/doi/abs/10.1063/5.0136130 doi:10.1063/5.0136130
[12] Badan Pengawas Obat dan Makanan. Peraturan Badan Pengawas Obat dan Makanan Nomor 23 Tahun 2022 tentang Standar dan/atau Persyaratan Mutu Obat dan Bahan Obat. 23. 2022 Oktober.
[13] Tarigan RE, Faisal H, Lase IK, Hafifah SP. Application Mean Centering Ratio Spectra Method for Ternary Mixture of Dextromethorphan Hbr, Doxylamine Succinate, And Pseudoephedrine Hcl in Tablet Preparations. Int J App Pharm. 2024 Jul 7;244–9. doi:10.22159/ijap.2024v16i4.50299
[14] Yuliasmi S, Muchlisyam, Reveny J, Gea S. Simultaneous Determination of Profenofos, Diazinon, And Chlorpyrifos in Ternarypesticidemixtures Using Mean Centeringofratiospectrophotometry.RJC.2026;19(03):1347–54. doi:10.31788/RJC.2026.1939645
[15] Mustafa DM, Magdy N, El Azab NF. Different spectrophotometric methods for simultaneous quantitation of Vericiguat and its alkaline degradation product: a comparative study with greenness profile assessment. Sci Rep. 2023 Dec 27;13(1):23077. doi:10.1038/s41598-023-50097-1
[16] ICH Guideline. International Conference on Harmonizati , ICH Q2(R2) Guideline on validation of analytical procedures. European Medicines Agency; 2023.
[17] Sitti Raodah Nurul Jannah, Sundani Nurono Soewandhi, Rachmat Mauludin, Handoyo Sahumena M. Preparasi dan Karakterisasi Interaksi Antarmolekular Glimepirid dan Metformin HCl dengan Metode Solvent Drop Grinding. LJIK. 2024 Apr 30;2(1):11–21. doi:10.33772/lansau.v2i1.21
[18] Sharkawi MMZ, Farid NF, Hassan MH, Hassan SA. New chemometrics-assisted spectrophotometric methods for simultaneous determination of co-formulated drugs montelukast, rupatadine, and desloratadine in their different dosage combinations. BMC Chemistry. 2024 Nov 19;18(1):232. doi:10.1186/s13065-024-01345-6
[19] Obaydo RH, Al Zakri DJ, Sakur AA, Lotfy HM. Ultraviolet spectrophotometric methods for the determination of the minor component presented in fixed-dose pharmaceutical combinations through the last two decades (2000–2020). Futur J Pharm Sci. 2021 Dec;7(1):44. doi:10.1186/s43094-021-00192-9
[20] Nasution LR, Muchlisyam, Putra EDL. Aplikasi Pengembangan Metode Spektrofotometri UV-Vis pada Analisis Simultan Isoniazid (INH) dan Vitamin B6 di dalam Sediaan Tablet. JFIOnline | Print ISSN 1412-1107 | e-ISSN 2355-696X. 2020 Jul 31;12(2):194–202. doi:10.35617/jfionline.v12i2.47
[21] Graham GG, Punt J, Arora M, Day RO, Doogue MP, Duong J, et al. Clinical Pharmacokinetics of Metformin. Clin Pharmacokinet. 2011 Feb 1;50(2):81–98. doi:10.2165/11534750-000000000-00000
[22] Kinani AAY, Taghi HS. Formulation and characterization of orodispersible tablet of glimepiride. Journal of Advanced Pharmaceutical Technology & Research. 2022 Oct;13(4):252–60. doi:10.4103/japtr.japtr_375_22
[23] Reichardt C, Welton T. Solvent Effects on the Absorption Spectra of Organic Compounds. In: Solvents and Solvent Effects in Organic Chemistry [Internet]. John Wiley & Sons, Ltd; 2010 [cited 2026 Sep 3]. p. 359–424. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/9783527632220.ch6 doi:10.1002/9783527632220.ch6
[24] Miller JN, Miller JC, Miller RD. Statistics and chemometrics for analytical chemistry. Seventh edition. Harlow, England London New York Boston San Francisco Toronto Sydney Dubai Singapore Hong Kong Tokyo Seoul Taipei New Dehli Cape Town São Paulo Mexico City Madrid Amsterdam Munich Paris Milan: Pearson; 2018. 1 p.
[25] Tim Penyusun; Direktorat Produksi dan Distribusi Kefarmasian. Farmakope Indonesia Edisi VI. VI. Jakarta: Kementerian Kesehatan Republik Indonesia.
[26] Afkhami A, Bahram M. Mean centering of ratio kinetic profiles as a novel spectrophotometric method for the simultaneous kinetic analysis of binary mixtures. Analytica Chimica Acta. 2004 Nov;526(2):211–8. doi:10.1016/j.aca.2004.09.064
[27] Zilhadia Z, Supandi S, Alfarisi S. Simultaneous Determination of Metformin and Glimepiride in Fixed-Dose Combination Tablets Sold in Pramuka Market using Validated UV Spectrophotometric Method. Jurnal Sains Farmasi & Klinis. 2021 Dec 6;8(3):303–8. doi:10.25077/jsfk.8.3.303-308.2021
Downloads
Published
Issue
Section
License
Copyright (c) 2026 Aufa Nurul Izzah Lubis, Masfria, Henny Sri Wahyuni
This work is licensed under a Creative Commons Attribution-NoDerivatives 4.0 International License.
Copyright in each article is the property of the Author.
