ARCHIVES
Year 2026 · Volume 6 · Issue 5
Review Article
A Sustainable Green Analytical Framework: Combining UV-Vis, IR, and Fluorescence Spectroscopy with Chemometric and Machine-Learning Models for the Accurate Quantification of Metformin and Sitagliptin
Prasanth.M1
Sowmiya.A2
Saravanan.V.S3
Prabhu.S4
Karthiraja.A.S5
Jambulingam.M6
1 2 3 4 5 6 Department of Pharmaceutical Analysis, The Erode College of Pharmacy, Veppampalayam, Erode, Tamilnadu, India. *Corresponding Author.
Published Online: September-October 2026
Pages: 87-97
Cite this article
↗ https://www.doi.org/10.59256/ijrtmr.20260605011
References
1. Ballav C, Gough SCL. Safety and efficacy of sitagliptin-metformin in fixed combination for the treatment of type 2 diabetes mellitus. Clin Med Insights Endocrinol Diabetes. 2013;6:23-31. https://pubmed.ncbi.nlm.nih.gov/24031162/
2. Chwieduk CM. Sitagliptin/metformin fixed-dose combination: in patients with type 2 diabetes mellitus. Drugs. 2011;71(3):349-361.https://pubmed.ncbi.nlm.nih.gov/21319871/
3. Mondal A, Naskar A, Siddiqi SS, et al. Efficacy and safety of fixed dose combination of sitagliptin, metformin, and pioglitazone in type 2 diabetes (IMPACT study): a randomized controlled trial. Cardiovasc Diabetol Endocrinol Rep. 2024;1:3.https://pubmed.ncbi.nlm.nih.gov/38336931/
4. Lakshmi KS, Lakshmi S. Design and optimization of a chemometric-assisted spectrophotometric determination of telmisartan and hydrochlorothiazide in pharmaceutical dosage form. Indian J Pharm Sci. 2010;72(5):574-578.https://pubmed.ncbi.nlm.nih.gov/21331198/
5. El-Bagary RI, Elkady EF, Ayoub BM. Spectrofluorometric and spectrophotometric methods for the determination of sitagliptin in binary mixture with metformin and ternary mixture with metformin and sitagliptin alkaline degradation product. Int J Biomed Sci. 2011;7(1):62-69.https://pubmed.ncbi.nlm.nih.gov/23675222/
6. Salim M, El-Enany N, Belal F, Walash M, Patonay G. Micelle-enhanced spectrofluorimetric method for determination of sitagliptin and identification of potential alkaline degradation products using LC-MS. Luminescence. 2014;29(7):837-845.https://pubmed.ncbi.nlm.nih.gov/23559485/
7. Azarian S, Shaghaghi M, Dehghan G, Sheibani N. A rapid, simple and ultrasensitive spectrofluorimetric method for the direct detection of metformin in real samples based on a nanoquenching approach. Luminescence. 2021;36(3):658-667.https://pubmed.ncbi.nlm.nih.gov/33185014/
8. Khan N, et al. Environmentally friendly protocol for the determination of sitagliptin phosphate in pharmaceutical preparations and biological fluids using l-tyrosine as a fluorescence probe. Luminescence. 2023;38(9):1456-1465.https://pubmed.ncbi.nlm.nih.gov/37519273/
9. Fahelelbom KMS, Saleh A, Mansour R, Sayed S. First derivative ATR-FTIR spectroscopic method as a green tool for the quantitative determination of diclofenac sodium tablets. F1000Research. 2020;9:172.https://pubmed.ncbi.nlm.nih.gov/32226614/
10. Remoto PJG, Gordon KC, Fraser-Miller SJ. A quantitative chemometric study of pharmaceutical tablet formulations using multi-spectroscopic fibre optic probes. Pharmaceuticals (Basel). 2024;17(12):1659.https://pubmed.ncbi.nlm.nih.gov/39770501/
11. Rahman A, et al. Green analytical techniques for impurity determination in pharmaceuticals. Electrophoresis. 2026;47(1-2):45-58.https://pubmed.ncbi.nlm.nih.gov/41351361/
12. Pena-Pereira F, Wojnowski W, Tobiszewski M. AGREE-Analytical GREEnness Metric Approach and Software. Anal Chem. 2020;92(14):10076-10082.https://pubmed.ncbi.nlm.nih.gov/32538619/
13. Yin L, Yu L, Guo Y, Wang C, Ge Y, Zheng X, Zhang N, You J, Zhang Y, Shi M. Green analytical chemistry metrics for evaluating the greenness of analytical procedures. J Pharm Anal. 2024;14(11):101013.https://pubmed.ncbi.nlm.nih.gov/39759968/
14. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.https://pubmed.ncbi.nlm.nih.gov/33577987/
15. Mansour FR, Omer KM, Płotka-Wasylka J. A total scoring system and software for complex modified GAPI (ComplexMoGAPI) application in the assessment of method greenness. Green Anal Chem. 2024;10:100126.https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Mansour+FR%2C+Omer+KM%2C+P%C5%82otka- Wasylka+J.+A+total+scoring+system+and+software+for+complex+modified+GAPI+%28ComplexMoGAPI%29+application+in+the+assessment+of+method+greenness.+Green+Anal+Chem.+2024%3B10%3A100126.&btnG=
16. Xin T, Yu L, Zhang W, Guo Y, Wang C, Li Z, You J, Xue H, Shi M, Yin L. Greenness evaluation metric for analytical methods and software. J Pharm Anal. 2025;101202.https://pubmed.ncbi.nlm.nih.gov/40756999/
17. Sänger-van de Griend CE. A practical approach to implementing ICH Q14: tools for analytical quality by design in capillary electrophoresis method development. Electrophoresis. 2025;46(13-14):933-953.https://pubmed.ncbi.nlm.nih.gov/40099702/
18. Contreras J, Bocklitz T. Explainable artificial intelligence for spectroscopy data: a review. Pflugers Arch. 2025;477:603-615.https://pubmed.ncbi.nlm.nih.gov/39088045/
19. Elnadi S, Abdalsabour S, Farouk M, Trabik YA. Fourier transform infrared spectroscopic, spectrofluorimetric assays of canagliflozin, and stability-indicating UV-spectrophotometric method for the simultaneous determination of canagliflozin and metformin. J AOAC Int. 2022;105(4):964-971.https://pubmed.ncbi.nlm.nih.gov/35348721/
20. Ramzy S, et al. Smart spectrophotometric methods for the simultaneous determination of newly co-formulated hypoglycemic drugs in binary mixtures. Spectrochim Acta A Mol Biomol Spectrosc. 2025;325:125123.https://pubmed.ncbi.nlm.nih.gov/33872950/
21. Attimarad M, Nair AB, Sreeharsha N, Al-Dhubiab BE, Venugopala KN, Shinu P. Development and validation of green UV derivative spectrophotometric methods for simultaneous determination of metformin and remogliflozin from formulation: evaluation of greenness. Int J Environ Res Public Health. 2021;18(2):448.https://pubmed.ncbi.nlm.nih.gov/33429964/
2. Chwieduk CM. Sitagliptin/metformin fixed-dose combination: in patients with type 2 diabetes mellitus. Drugs. 2011;71(3):349-361.https://pubmed.ncbi.nlm.nih.gov/21319871/
3. Mondal A, Naskar A, Siddiqi SS, et al. Efficacy and safety of fixed dose combination of sitagliptin, metformin, and pioglitazone in type 2 diabetes (IMPACT study): a randomized controlled trial. Cardiovasc Diabetol Endocrinol Rep. 2024;1:3.https://pubmed.ncbi.nlm.nih.gov/38336931/
4. Lakshmi KS, Lakshmi S. Design and optimization of a chemometric-assisted spectrophotometric determination of telmisartan and hydrochlorothiazide in pharmaceutical dosage form. Indian J Pharm Sci. 2010;72(5):574-578.https://pubmed.ncbi.nlm.nih.gov/21331198/
5. El-Bagary RI, Elkady EF, Ayoub BM. Spectrofluorometric and spectrophotometric methods for the determination of sitagliptin in binary mixture with metformin and ternary mixture with metformin and sitagliptin alkaline degradation product. Int J Biomed Sci. 2011;7(1):62-69.https://pubmed.ncbi.nlm.nih.gov/23675222/
6. Salim M, El-Enany N, Belal F, Walash M, Patonay G. Micelle-enhanced spectrofluorimetric method for determination of sitagliptin and identification of potential alkaline degradation products using LC-MS. Luminescence. 2014;29(7):837-845.https://pubmed.ncbi.nlm.nih.gov/23559485/
7. Azarian S, Shaghaghi M, Dehghan G, Sheibani N. A rapid, simple and ultrasensitive spectrofluorimetric method for the direct detection of metformin in real samples based on a nanoquenching approach. Luminescence. 2021;36(3):658-667.https://pubmed.ncbi.nlm.nih.gov/33185014/
8. Khan N, et al. Environmentally friendly protocol for the determination of sitagliptin phosphate in pharmaceutical preparations and biological fluids using l-tyrosine as a fluorescence probe. Luminescence. 2023;38(9):1456-1465.https://pubmed.ncbi.nlm.nih.gov/37519273/
9. Fahelelbom KMS, Saleh A, Mansour R, Sayed S. First derivative ATR-FTIR spectroscopic method as a green tool for the quantitative determination of diclofenac sodium tablets. F1000Research. 2020;9:172.https://pubmed.ncbi.nlm.nih.gov/32226614/
10. Remoto PJG, Gordon KC, Fraser-Miller SJ. A quantitative chemometric study of pharmaceutical tablet formulations using multi-spectroscopic fibre optic probes. Pharmaceuticals (Basel). 2024;17(12):1659.https://pubmed.ncbi.nlm.nih.gov/39770501/
11. Rahman A, et al. Green analytical techniques for impurity determination in pharmaceuticals. Electrophoresis. 2026;47(1-2):45-58.https://pubmed.ncbi.nlm.nih.gov/41351361/
12. Pena-Pereira F, Wojnowski W, Tobiszewski M. AGREE-Analytical GREEnness Metric Approach and Software. Anal Chem. 2020;92(14):10076-10082.https://pubmed.ncbi.nlm.nih.gov/32538619/
13. Yin L, Yu L, Guo Y, Wang C, Ge Y, Zheng X, Zhang N, You J, Zhang Y, Shi M. Green analytical chemistry metrics for evaluating the greenness of analytical procedures. J Pharm Anal. 2024;14(11):101013.https://pubmed.ncbi.nlm.nih.gov/39759968/
14. Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.https://pubmed.ncbi.nlm.nih.gov/33577987/
15. Mansour FR, Omer KM, Płotka-Wasylka J. A total scoring system and software for complex modified GAPI (ComplexMoGAPI) application in the assessment of method greenness. Green Anal Chem. 2024;10:100126.https://scholar.google.com/scholar?hl=en&as_sdt=0%2C5&q=Mansour+FR%2C+Omer+KM%2C+P%C5%82otka- Wasylka+J.+A+total+scoring+system+and+software+for+complex+modified+GAPI+%28ComplexMoGAPI%29+application+in+the+assessment+of+method+greenness.+Green+Anal+Chem.+2024%3B10%3A100126.&btnG=
16. Xin T, Yu L, Zhang W, Guo Y, Wang C, Li Z, You J, Xue H, Shi M, Yin L. Greenness evaluation metric for analytical methods and software. J Pharm Anal. 2025;101202.https://pubmed.ncbi.nlm.nih.gov/40756999/
17. Sänger-van de Griend CE. A practical approach to implementing ICH Q14: tools for analytical quality by design in capillary electrophoresis method development. Electrophoresis. 2025;46(13-14):933-953.https://pubmed.ncbi.nlm.nih.gov/40099702/
18. Contreras J, Bocklitz T. Explainable artificial intelligence for spectroscopy data: a review. Pflugers Arch. 2025;477:603-615.https://pubmed.ncbi.nlm.nih.gov/39088045/
19. Elnadi S, Abdalsabour S, Farouk M, Trabik YA. Fourier transform infrared spectroscopic, spectrofluorimetric assays of canagliflozin, and stability-indicating UV-spectrophotometric method for the simultaneous determination of canagliflozin and metformin. J AOAC Int. 2022;105(4):964-971.https://pubmed.ncbi.nlm.nih.gov/35348721/
20. Ramzy S, et al. Smart spectrophotometric methods for the simultaneous determination of newly co-formulated hypoglycemic drugs in binary mixtures. Spectrochim Acta A Mol Biomol Spectrosc. 2025;325:125123.https://pubmed.ncbi.nlm.nih.gov/33872950/
21. Attimarad M, Nair AB, Sreeharsha N, Al-Dhubiab BE, Venugopala KN, Shinu P. Development and validation of green UV derivative spectrophotometric methods for simultaneous determination of metformin and remogliflozin from formulation: evaluation of greenness. Int J Environ Res Public Health. 2021;18(2):448.https://pubmed.ncbi.nlm.nih.gov/33429964/
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