Search

Search by keyword or author

HPTLC Driven Analytical Approaches for Antidiabetic Pharmaceuticals: A Detailed Review

Home > 2025, Vol. 13 No. 02 > HPTLC Driven Analytical Approaches for Antidiabetic Pharmaceuticals: A Detailed Review
Published: May 15, 2026
Download PDF
Download HTML

Authors

Atul A. Shirkhedkar, Amod S. Patil, Inderbir Singh, Gurbinder Kaur, and Tejas Raju Jorvekar

DOI Number
https://doi.org/10.15415/jptrm.2025.132003
Keywords
HPTLC, Antidiabetic drugs, Analytical methods, Validation

Abstract

Background: Diabetes mellitus is a chronic disease affecting a large number of populations across the world, and it also requires management using anti-diabetic drugs. Various drugs such as metformin, vildagliptin, saxagliptin, sitagliptin, rosiglitazone, glipizide, and their combinations are commonly used for the treatment. Numerous pharmaceutical formulations are available in the market in combination forms as well. In order to ensure the quality, appropriate dosage, and regulatory compliance of these formulations, accurate and reliable analytical methods are essential.

Purpose: This review will provide comprehensive insight into HPTLC-based analytical approaches used for qualitative and quantitative analysis of anti-diabetic drugs in various pharmaceutical formulations.

Methods: This review critically summarizes the literature reporting HPTLC methods developed for the analysis of anti-diabetic drugs. Key aspects such as HPTLC method development, mobile phase and stationary phase selection, detection methods, and optimization strategies are discussed. Method validation parameters such as robustness, sensitivity, reproducibility, and accuracy are mentioned.

Results: The study demonstrated that the HPTLC method is a reliable and efficient analytical technique for the evaluation of anti-diabetic drugs due to its low cost, high reproducibility, minimal solvent consumption, and ability to analyze multiple samples simultaneously. For routine quality control and research applications, validated HPTLC methods have shown satisfactory performance.

Conclusion: HPTLC represents itself as a valuable tool for the qualitative as well as quantitative assessment of anti-diabetic formulations. This detailed review provides guidance for researchers as well as analysts in selecting and optimizing appropriate HPTLC protocols for research and quality control purposes. It also highlights the potential for further advancements in HPTLC-based drug analysis.

References

  • Ahir, K. B., Patelia, E. M., & Shah, A. (2013). Simultaneous estimation of metformin hydrochloride and repaglinide in pharmaceutical formulation by HPTLC-densitometry method. Journal of Chromatography & Separation Techniques, 4(1), 166. https://doi.org/10.4172/2157-7064.1000166
  • Akabari, A. H., Gajiwala, H., Patel, S. K., Surati, J., Solanki, D., Shah, K. V., Patel, T. J., & Patel, S. P. (2025). Stability-indicating TLC-densitometric and HPLC methods for simultaneous determination of teneligliptin and pioglitazone in pharmaceutical dosage forms with eco-friendly assessment. Journal of Chromatographic Science, 63(2), bmae038. https://doi.org/10.1093/chromsci/bmae038
  • Attimarad, M., Elgorashe, R. E., Subramaniam, R., Islam, M. M., Venugopala, K. N., Nagaraja, S., & Balgoname, A. A. (2020). Development and validation of rapid RP-HPLC and green second-derivative UV spectroscopic methods for simultaneous quantification of metformin and remogliflozin in formulation using experimental design. Separations, 7(4), 59. https://doi.org/10.3390/separations7040059
  • Badke, S. V., Kakad, K. S., & Malode, S. S. (2022). High-performance thin-layer chromatography (HPTLC) method development and validation for determination of remogliflozin etabonate and vildagliptin in bulk and its tablet formulation. International Journal of Applied Pharmaceutics, 14, 147–153. https://doi.org/10.22159/ijap.2022.v14ti.42
  • Chaudhury, A., Duvoor, C., Reddy Dendi, V. S., Kraleti, S., Chada, A., Ravilla, R., Marco, A., Shekhawat, N. S., Montales, M. T., Kuriakose, K., & Sasapu, A. (2017). Clinical review of antidiabetic drugs: Implications for type 2 diabetes mellitus management. Frontiers in Endocrinology, 8, 6. https://doi.org/10.3389/fendo.2017.00006
  • Chavan, V., Ghante, M., & Sawant, S. (2014). Development and validation of RP-HPLC method for simultaneous estimation of sitagliptin phosphate and simvastatin in bulk and dosage form. Journal of Applied Pharmacy, 6, 327–338.
  • Connelly, J. (2017). ICH Q3C impurities: Guideline for residual solvents. In ICH quality guidelines: An implementation guide (pp. 199–232). Wiley.
  • Dhole, S. M., Khedekar, P. B., & Amnerkar, N. D. (2013). Development and validation of HPTLC densitometry method for simultaneous estimation of rosiglitazone and glimepiride in fixed tablet dosage form. Journal of the Chilean Chemical Society, 58(2), 1663–1666. https://doi.org/10.4067/S0717-97072013000200004
  • El-Desouky, E. A., Abdel-Raoof, A. M., Abdel-Fattah, A., Abdel-Zaher, A., Osman, A. O., Abdel-Monem, A. H., & Morshedy, S. (2021). Determination of linagliptin and empagliflozin by UPLC and HPTLC techniques aided by lean six sigma approach. Biomedical Chromatography, 35(7), e5102. https://doi.org/10.1002/bmc.5102
  • Feingold, K. R. (2024). Cholesterol lowering drugs. In K. R. Feingold, B. Anawalt, & A. Boyce (Eds.), Endotext. https://www.ncbi.nlm.nih.gov/books/NBK395573
  • Gope, E. R., Begum, S. M., Anisetti, P. P., Kasa, G. G., Eedarada, V. G., Nalli, J., & Thummidi, R. S. (2024). A review of principles, applications, and recent developments in HPTLC and HPLC. Journal of Pharma Insights and Research, 2(6), 56–64. https://doi.org/10.69613/315vge42
  • Görög, S. (2011). Advances in the analysis of steroid hormone drugs in pharmaceuticals and environmental samples (2004–2010). Journal of Pharmaceutical and Biomedical Analysis, 55(4), 728–743. https://doi.org/10.1016/j.jpba.2010.11.011
  • Harris, K. B., & McCarty, D. J. (2015). Efficacy and tolerability of glucagon-like peptide-1 receptor agonists in patients with type 2 diabetes mellitus. Therapeutic Advances in Endocrinology and Metabolism, 6(1), 3–18. https://doi.org/10.1177/2042018814558242
  • Havele, S. S., & Dhaneshwar, S. R. (2010). Determination of glibenclamide in tablets by densitometric HPTLC. Der Pharmacia Lettre, 2(4), 440–446.
  • Havele, S., & Dhaneshwar, S. (2010). Estimation of metformin in bulk drug and in formulation by HPTLC. Journal of Nanomedicine & Nanotechnology, 1(102), 1–3. https://doi.org/10.4172/2157-7439.1000102
  • Inflibnet. (n.d.). High performance thin layer chromatography (HPTLC) – Analytical chemistry. Retrieved January 7, 2025, from https://ebooks.inflibnet.ac.in/esp02/chapter/high-performance-thin-layer-chromatography-hptlc/
  • Inzucchi, S. E., Lipska, K. J., Mayo, H., Bailey, C. J., & McGuire, D. K. (2014). Metformin in patients with type 2 diabetes and kidney disease: A systematic review. JAMA, 312(24), 2668–2675. https://doi.org/10.1001/jama.2014.15298
  • Ismail-Beigi, F. (2012). Pathogenesis and glycemic management of type 2 diabetes mellitus: A physiological approach. Archives of Iranian Medicine, 15(4), 239–246.
  • Jain, P. S., Patel, M. K., & Surana, S. J. (2013). Development and validation of stability-indicating high-performance thin-layer chromatography method for estimation of repaglinide in bulk and in pharmaceutical formulation. Acta Chromatographica, 25(3), 531–544. https://doi.org/10.1556/achrom.25.2013.3.9
  • Kalász, H., & Báthori, M. (2001). Pharmaceutical applications of TLC. LC GC Europe, 14(5), 311–321.
  • Kaur, I., Wakode, S., & Singh, H. P. (2016). Development and validation of a stability-indicating high-performance thin layer chromatography (HPTLC) method for estimation of canagliflozin in bulk and pharmaceutical dosage form. Journal of Applied Pharmaceutical Science, 6(5), 51–57. https://doi.org/10.7324/JAPS.2016.60508
  • Kumar, P. J., & Clark, M. (2002). Textbook of clinical medicine. Saunders.
  • McCalley, D. V. (2003). Selection of suitable stationary phases and optimum conditions for their application in the separation of basic compounds by reversed-phase HPLC. Journal of Separation Science, 26(3–4), 187–200. https://doi.org/10.1002/jssc.200390026
  • Modi, D. K., & Patel, B. H. (2012). Simultaneous determination of metformin hydrochloride and glipizide in tablet formulation by HPTLC. Journal of Liquid Chromatography & Related Technologies, 35(1), 28–39. https://doi.org/10.1080/10826076.2011.593227
  • Munde, M. K., Kulkarni, N. S., Sen, A. K., & Sen, D. B. (2020). A novel validated stability indicating analytical method for simultaneous quantification of metformin hydrochloride and empagliflozin in bulk and marketed formulation by HPTLC using box–Wilson experimental design approach. BMC Chemistry, 17(1), 110. https://doi.org/10.1186/s13065-023-00969
  • Nyiredy, S. (2002). Planar chromatographic method development using the PRISMA optimization system and flow charts. Journal of Chromatographic Science, 40(10), 553–563. https://doi.org/10.1093/chromsci/40.10.553
  • Patel, K. K., Karkhanis, V. V., & Gajjar, S. S. (2015). Development and validation of stability indicating HPTLC method for estimation of glimepiride and metformin hydrochloride. International Journal of Pharmaceutical Sciences and Research, 6(3), 1222–1228. https://doi.org/10.13040/IJPSR.0975-8232.6(3).1222-29
  • Patel, P. D., & Pandya, S. S. (2018). A review on analytical methods for determination of oral anti-diabetic drugs like biguanides, gliptins and gliflozins in bulk and pharmaceutical dosage forms. World Journal of Pharmaceutical Sciences, 6(1), 29–39.
  • Pawar, S., Patel, J., Sharma, R., Khan, S., & Patel, R. (2022). Method development and validation for anti-diabetic drugs by RP-HPLC. International Journal of Pharmaceutical Sciences & Medicine, 7(10), 6–29. https://doi.org/10.47760/IJPSM.2022.V07I10.002
  • Poole, C. F. (2003). Thin-layer chromatography: Challenges and opportunities. Journal of Chromatography A, 1000(1–2), 963–984. https://doi.org/10.1016/S0021-9673(03)00435-7
  • Poznyak, A., Grechko, A. V., Poggio, P., Myasoedova, V. A., Alfieri, V., & Orekhov, A. N. (2020). The diabetes mellitus–atherosclerosis connection: The role of lipid and glucose metabolism and chronic inflammation. International Journal of Molecular Sciences, 21(5), 1835. https://doi.org/10.3390/ijms21051835
  • Prajapati, P., Rana, B., Pulusu, V. S., & Mishra, A. (2024). Multipurpose RP-HPLC method for simultaneous estimation of fixed-dose combinations of anti-diabetic drugs: integrating green, economical, and robust approaches with design of experiments and white analytical chemistry. Chemistry Africa, 7(3), 1385-1400. https://doi.org/10.1007/s42250-023-00835-9
  • Puavilai, G., Chanprasertyotin, S., & Sriphrapradaeng, A. (1999). Diagnostic criteria for diabetes mellitus and other categories of glucose intolerance: 1997 criteria by the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus (ADA), 1998 WHO consultation criteria, and 1985 WHO criteria. Diabetes research and clinical practice, 44(1), 21-26.  https://doi.org/10.1016/S0168-8227(99)00008-X
  • Rana, K., & Sharma, P. (2021). Analytical method development and validation for the simultaneous estimation of metformin hydrochloride and alogliptin by RP-HPLC in bulk and tablet dosage forms. Research Journal of Science and Technology, 13(2), 111–118. https://doi.org/10.52711/2349-2988.2021.00018
  • Rao, N. M., & Konda, R. (2020). Development and validation of high-performance thin layer chromatographic method for the determination of voglibose in bulk and their formulations. Letters in Applied NanoBioScience, 9(2), 1074–1078. https://doi.org/10.33263/LIANBS92.10741078
  • Rossi, M. C., Nicolucci, A., Ozzello, A., Gentile, S., Aglialoro, A., Chiambretti, A., … & Cucinotta, D. (2019). Impact of severe and symptomatic hypoglycemia on quality of life and fear of hypoglycemia in type 1 and type 2 diabetes. Results of the Hypos-1 observational study. Nutrition, Metabolism and Cardiovascular Diseases, 29(7), 736-743. https://doi.org/10.1016/j.numecd.2019.04.009
  • Sapra, A., & Bhandari, P. (2024). StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK551501
  • Sethi, P. D. (1996). High-performance thin-layer chromatography: Quantitative analysis of pharmaceutical formulations. CBS Publishers & Distributors, New Delhi.
  • Sharma, K., & Parle, A. (2015). Development and validation of HPTLC method for estimation of alogliptin benzoate. International Bulletin of Drug Research, 5(8), 81–89.
  • Shewiyo, D. H., Kaale, E. A. K. K., Risha, P. G., Dejaegher, B., Smeyers-Verbeke, J., & Vander Heyden, Y. (2012). HPTLC methods to assay active ingredients in pharmaceutical formulations: A review of the method development and validation steps. Journal of pharmaceutical and biomedical analysis, 66, 11-23. https://doi.org/10.1016/j.jpba.2012.03.034
  • Shirode, A. R., Maduskar, P. D., Deodhar, M. S., & Kadam, V. J. (2014). RP-HPLC and HPTLC Methods for Simultaneous Estimation of Metformin Hydrochloride and Vildagliptin from Bulk and Marketed Formulation: Development and Validation. British Journal of Pharmaceutical Research, 4(20), 2370–2386. https://doi.org/10.9734/BJPR/2014/12820
  • Shukla, A., Chhalotiya, U., Shah, D., Tandel, J., Kachhiya, H., & Parmar, M. (2024). Development and validation of stability indicating HPTLC method for simultaneous estimation of dapagliflozin and linagliptin. Discover Chemistry, 1(1), Article 4. https://doi.org/10.1007/s44371-024-00002-0
  • Spangenberg, B., Poole, C. F., & Weins, C. (2011). Quantitative thin-layer chromatography: A practical survey. Springer. https://doi.org/10.1007/978-3-642-10729-0
  • Srivani, J., Umamahesh, B., & Veeresham, C. J. (2016). Development and validation of stability indicating HPTLC method for simultaneous determination of linagliptin and metformin. International Journal of Pharmacy and Pharmaceutical Sciences, 8(1), 112–115.
  • Srividya, S., Swetha, E., & Veeresham, C. (2015). Quantitative analysis of saxagliptin by stability indicating HPTLC method in bulk and pharmaceutical dosage form. American Journal of Analytical Chemistry, 6(10), 797–804. https://doi.org/10.4236/ajac.2015.610076
  • Suma, B. V., Deveswaran, R., & Premnath, S. H. (2019). HPTLC method development of dapagliflozin. International Journal of Pharmacy and Pharmaceutical Sciences, 11(8), 58–63. https://doi.org/10.22159/ijpps.2019v11i8.34339
  • Thomas, A. B., Patil, S. D., Nanda, R. K., Kothapalli, L. P., Bhosle, S. S., & Deshpande, A. D. (2011). Stability-indicating HPTLC method for simultaneous determination of nateglinide and metformin hydrochloride in pharmaceutical dosage form. Saudi Pharmaceutical Journal, 19(4), 221–231. https://doi.org/10.1016/j.jsps.2011.06.005
  • Varaprasad, C., Asif, M., & Ramakrishna, K. (2015). RP-HPLC method for simultaneous estimation of metformin and linagliptin in tablet dosage form. Rasayan Journal of Chemistry, 8(4), 426–432.
  • Vichare, V. S., Choudhari, V. P., & Reddy, M. V. (2022). Development of new validated HPTLC method for simultaneous estimation of canagliflozin and metformin in tablet formulation. Research Journal of Pharmacy and Technology, 15(6), 2599–2604. https://doi.org/10.52711/0974-360X.2022.00434
  • Waksmundzka-Hajnos, M., Sherma, J., & Kowalska, T. (2008). Thin-layer chromatography in phytochemistry. CRC Press. https://doi.org/10.1201/9781420046786

How to Cite

Atul A. Shirkhedkar, Amod S. Patil, Inderbir Singh, Gurbinder Kaur, and Tejas Raju Jorvekar. HPTLC Driven Analytical Approaches for Antidiabetic Pharmaceuticals: A Detailed Review. J. Pharm. Technol. Res. Manag.. 2025, 13, 48-59
HPTLC Driven Analytical Approaches for Antidiabetic Pharmaceuticals: A Detailed Review

Current Issue

PeriodicityBiannually
Issue-1June
Issue-2December
ISSN Print2321-2217
ISSN Online2321-2225
RNI No.CHAENG/2013/50088

This work is licensed under a Creative Commons Attribution 4.0 International License.

Articles in Journal of Pharmaceutical Technology, Research and Management (J. Pharm. Tech. Res. Management) by Chitkara University Publications are Open Access articles that are published with licensed under a Creative Commons Attribution- CC-BY 4.0 International License. Based on a work at https://jptrm.chitkara.edu.in/. This license permits one to use, remix, tweak and reproduction in any medium, even commercially provided one give credit for the original creation.

View Legal Code of the above-mentioned license, https://creativecommons.org/licenses/by/4.0/legalcode

View Licence Deed here https://creativecommons.org/licenses/by/4.0/

Creative Commons License

Journal of Pharmaceutical Technology, Research and Management by Chitkara University Publications is licensed under a Creative Commons Attribution 4.0 International License.
Based on a work at https://jptrm.chitkara.edu.in//

Visibility, Memberships and Ethics

Chitkara University

Chitkara University

India’s top rated university

Chandigarh-Patiala National Highway, Punjab 140 401

Chandigarh Information Center SCO 160-161, Sector 9-C, Chandigarh 160 009

Publisher

Corporate Office

Chitkara University Publications
Administrative Office, Saraswati Kendra
P.O. Box No. 70,
SCO 160-161, Sector- 9C, Chandigarh-160009, India.

Email: chitkarauniversitypublications@chitkara.edu.in

Editorial Office

Centre for Research Impact and Outcome
4th floor, Darwin Block
Chandigarh-Patiala National Highway, Rajpura
Punjab-140401, India
Email: editor.jptrm@chitkara.edu.in, journals@chitkara.edu.in

For journal please visit the website: https://jptrm.chitkara.edu.in/

The "Journal of Pharmaceutical Technology, Research and Management” is a peer-reviewed, refereed, bi-annual open-access Journal of "Chitkara University Publications".

ISSN (p): 2321-2217 ; ISSN (e): 2321-2225 ; RNI No: CHAENG/2013/50088

Copyright ©2023 Chitkara Educational Trust | All rights reserved
Explore Your Potential

Chandigarh-Patiala National Highway, Punjab 140 401

Chandigarh Information Center SCO 160-161, Sector 9-C, Chandigarh 160 009

×
✔

Thank You!

Your form has been submitted successfully.