Skip to main content
SpringerLink
Log in

Normal- and reversed-phase high-performance thin-layer chromatography methods for the simultaneous determination of remogliflozin etabonate and metformin hydrochloride antidiabetic drugs in bulk and tablet formulation

  • Original Research Paper
  • Published:
JPC – Journal of Planar Chromatography – Modern TLC Aims and scope Submit manuscript

Abstract

Two new, simple, fast, and sensitive methods, normal- and reversed-phase high-performance thin-layer chromatography (NP-HPTLC and RP-HPTLC) were established for the simultaneous determination of the antidiabetic drugs remogliflozin etabonate (REM) and metformin hydrochloride (MET) in bulk and tablet formulation. NP-HPTLC was performed using aluminum plates pre-coated with silica gel 60 NP F254 as the stationary phase using ethyl acetate‒methanol‒toluene‒formic acid (1.25:0.5:2.25:1, V/V) as the mobile phase. However, good separation was achieved for RP-HPTLC on aluminum plates pre-coated with silica gel 60 RP-18 F254S as the stationary phase using water‒methanol‒glacial acetic acid (2.5:1.5:1, V/V) as the mobile phase. Quantification was done by densitometric analysis at 226 nm for both methods over the concentration range of 200‒1200 ng/band for REM and 1000‒6000 ng/band for MET. The developed method was validated in terms of linearity, accuracy, precision, robustness, ruggedness, and specificity. Linear regression analysis data for calibration of the HPTLC method represented a good linear relationship with regression coefficient: r2 > 0.99 for both methods. The compact spots of REM and MET showed RF values of 0.56 and 0.10 in NP-HPTLC and 0.15 and 0.88 in RP-HPTLC method, respectively. The developed NP-HPTLC method was used for the analysis of REM and MET in tablet formulation, and the percentage amount was found to be in the range of 100.28‒100.78% and 100.25‒100.73%, respectively; the lower limits of detection and quantification (LOD and LOQ) were 17.86 ng and 54.12 ng for REM and 105.04 ng and 318.32 ng for MET. Furthermore, in RP-HPTLC method, the percentage amounts were found to be in the range of 100.28‒100.66% and 100.32‒100.80% for REM and MET, respectively. LOD and LOQ were 16.94 ng and 51.34 ng for REM and 114.86 and 348.05 for MET.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5

Similar content being viewed by others

Abbreviations

REM:

Remogliflozin etabonate

MET:

Metformin hydrochloride

NP-HPTLC:

Normal-phase high-performance thin-layer chromatography

RP-HPTLC:

Reversed-phase high-performance thin-layer chromatography

HPLC:

High-performance liquid chromatography

R F :

Retention factor

AR:

Analytical reagent

%RSD:

Percent relative standard deviation

LOD:

Limit of detection

LOQ:

Limit of quantification

SD:

Standard deviation

References

  1. Sami W, Ansari T, Butt NS, Hamid MRA (2017) Effect of diet on type 2 diabetes mellitus: a review. Int J Health Sci 11(2):65–71. https://doi.org/10.1002/dmrr.2515

    Article  CAS  Google Scholar 

  2. Lin Y, Sun Z (2010) Current views on type 2 diabetes. J Endocrinol 204:1–11. https://doi.org/10.1677/JOE-09-0260

    Article  CAS  PubMed  Google Scholar 

  3. Rena G, Hardie DG, Pearson ER (2017) The mechanisms of action of metformin. Diabetologia 60:1577–1585. https://doi.org/10.1007/s00125-017-4342-z

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  4. Jabbour S, Ziring B (2011) Advantages of extended-release metformin in patients with type 2 diabetes mellitus. Postgrad Med 123(1):15–23. https://doi.org/10.3810/pgm.2011.01.2241

    Article  PubMed  Google Scholar 

  5. Setter S, Iltz J, Thams J, Campbell R (2004) Metformin hydrochloride in the treatment of type 2 diabetes mellitus: a clinical review with a focus on dual therapy. Clin Ther 25(12):2991–3026. https://doi.org/10.1016/S0149-2918(03)90089-0

    Article  Google Scholar 

  6. Mohan V, Mithal A, Joshi SR, Aravind SR, Chowdhury S (2020) Remogliflozin etabonate in the treatment of type 2 diabetes: design, development, and place in therapy. Drug Des Devel Ther 14:2487–2501. https://doi.org/10.2147/DDDT.S221093

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  7. Markham A (2019) Remogliflozin etabonate: first global approval. Drugs 79:1157–1161. https://doi.org/10.1007/s40265-019-01150-9

    Article  CAS  PubMed  Google Scholar 

  8. Tammisetty M, Challa B, Puttagunta SB (2021) A novel analytical method for the simultaneous estimation of remogliflozin and metformin hydrochloride by UPLC/PDA in bulk and formulation. Application to the estimation of product traces. Turk J Pharm Sci 18(3):296–305. https://doi.org/10.4274/tjps.galenos.2020.39699

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  9. Attimarad M, Elgorashe RE, Subramaniam R, Islam MM, Venugopala KN, Nagaraja S, Balgoname AA (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(59):1–20. https://doi.org/10.3390/separations7040059

    Article  CAS  Google Scholar 

  10. Shivani VT (2021) Stabilty indicating RP-HPLC method development and validation for simultaneous estimation of remogliflozin etabonate and metformin hcl in synthetic mixture and tablet dosage form. World J Pharm Res 10(10):981–993. https://doi.org/10.20959/wjpr202110-21237

    Article  CAS  Google Scholar 

  11. Patel VA, Pandya CV, Patel ZJ, Patel DR, Pandya AC (2021) Development and validation of novel RP-UHPLC/DAD methods for simultaneous quantification of remogliflozin and metformin in bulk and formulation. Rasayan J Chem 14(2):1384–1393. https://doi.org/10.31788/%20RJC.2021.1426295

    Article  CAS  Google Scholar 

  12. Vasa R, Vasa N, Tiwar N, Patani P, Solanki B (2021) Development and validation of stability indicating RP-HPLC method for estimation of metformin and remogliflozin etabonate in pharmaceutical dosage form. Int J All Res Educ Sci Methods 9(5):4079–4093

    Google Scholar 

  13. Attimarad M, Nair AB, Sreeharsha N, Al-Dhubiab BE, Venugopala KN, Shinu P (2021) Development and validation of green UV derivative spectrophotometric methods for simultaneous determination metformin and remogliflozin from formulation: evaluation of greenness. Int J Environ Res Public Health 18(448):1–16

    Google Scholar 

  14. Attimarad M, Nair AB, Nagaraja S, Aldhubiab BE, Venugopala KN, Pottathil S (2021) Smart UV derivative spectrophotometric methods for simultaneous determination of metformin and remogliflozin: development, validation and application to the formulation. Indian J Pharm Educ Res 55(1):S293–S302

    CAS  Google Scholar 

  15. Patel BM, Hinge M (2021) Development and validation of UV spectrophotometric method for the simultaneous estimation of remogliflozin etabonate and metformin hydrochloride in their pharmaceutical dosage form. Int J All Res Educ Sci Methods 9(6):459–465

    Google Scholar 

  16. Kamal AH, El-Malla SF, Hammad SF (2016) A review on UV spectrophotometric methods for simultaneous multicomponent analysis. Eur J Pharm Med Res 3(2):348–360

    Google Scholar 

  17. Vidhi D, Patel P (2021) Method development and validation of UV spectrophotometric estimation of remogliflozin etabonate in bulk and its tablet dosage form. Res J Pharm Technol 14(4):2042–2044

    Article  Google Scholar 

  18. Tayade AB, Patil AS, Shirkhedkar AA (2019) Development and validation of zero order UV spectrophotometric method by area under curve technique and high-performance thin layer chromatography for the estimation of remogliflozin etabonate in bulk and in house tablets. Inventi Rapid Pharm Anal Qual Assur 3:1–5

    Google Scholar 

  19. Itigimatha N, Chadchan KS, Yallur BC, Hadagali MD (2022) Simple and sensitive RP-HPLC and UV spectroscopic methods for the determination of remogliflozin etabonate in pure and pharmaceutical formulations. Turk J Pharm Sci 19(2):213–219. https://doi.org/10.4274/tjps.galenos.2021.55381

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  20. Shah DA, Gondalia II, Patel VB, Mahajan A, Chhalotiya UK (2020) Stability indicating liquid chromatographic method for the estimation of remogliflozin etabonate. J Chem Metrol 14(2):125–132. https://doi.org/10.25135/jcm.46.20.07.1734

    Article  Google Scholar 

  21. Kanna KL, Panigrahy UP (2021) Stability indicating method development and validation of remogliflozin etabonate in bulk and pharmaceutical dosage form by RP-HPLC. Int J Pharm Sci Res. 12(8):4197–4207. https://doi.org/10.13040/IJPSR.0975-8232.12(8).4197-07

    Article  CAS  Google Scholar 

  22. Shah DA, Gondalia II, Patel VB, Mahajan A, Chhalotiya U, Nagda DC (2021) Stability indicating thin-layer chromatographic method for estimation of antidiabetic drug remogliflozin etabonate. Future J Pharm Sci 7:1–12. https://doi.org/10.1186/s43094-021-00230-6

    Article  Google Scholar 

  23. Jadhav SR, Deshpande PB, Swami S, Supe D (2021) A validated stability indicating high performance thin layer chromatographic method for determination of remogliflozin etabonate in tablet dosage form. Int J Chem Tech Res 14(3):382–390

    CAS  Google Scholar 

  24. Al-Janabi WSK, Mahmood AK, Luaibi HM (2020) Determination of the dissociation constants of metformin from a second derivative UV spectrum. Int J Res Pharm Sci 11(1):790–796. https://doi.org/10.26452/ijrps.v11i1.1896

    Article  CAS  Google Scholar 

  25. Chhetri HP, Thapa P, Schepdael AV (2014) Simple HPLC-UV method for the quantification of metformin in human plasma with one step protein precipitation. Saudi Pharm J 22(5):483–487. https://doi.org/10.1016/j.jsps.2013.12.011

    Article  PubMed  Google Scholar 

  26. Chaudhari K, Wang J, Xu Y, Winters A, Wang L, Dong X, Cheng EY, Liu R, Yang SH (2020) Determination of metformin bio-distribution by LC-MS/MS in mice treated with a clinically relevant paradigm. PLOS ONE 15(6):e0234571. https://doi.org/10.1371/journal.pone.0234571

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  27. Ali I, Aboul-Enein HY, Gupta VK (2007) Analysis of metformin dosage formulations by capillary electrophoresis at nano scale detection. Comb Chem High Throughput Screen 10:611–615

    Article  CAS  PubMed  Google Scholar 

  28. Imran M, Iqubal MK, Ahmad S, Ali J, Baboota S (2019) Stability-indicating high-performance thin-layer chromatographic method for the simultaneous determination of quercetin and resveratrol in the lipid-based nanoformulation. JPC–J Planar Chromatogr–Mod TLC 32(5):393–400

    Article  CAS  Google Scholar 

  29. Rathod RH, Patil AS, Shirkhedkar AA (2018) Novel NP and RP-HPTLC in praxis for simultaneous estimation of chlorthalidone and cilnidipine in bulk and pharmaceutical formulation. Anal Chem Lett 8(6):862–871. https://doi.org/10.1080/22297928.2018.1527252

    Article  CAS  Google Scholar 

  30. ICH Harmonised Tripartite Guideline (2005) Validation of analytical procedures: text and methodology Q2 (R1). In: Proceedings of the International Conference on Harmonization (ICH ’05), Geneva

  31. International Council for Harmonization (2022) Validation of analytical procedures. Geneva Q2(R2):11–12

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Pharmaceutical Chemistry, R.C. Patel Institute of Pharmaceutical Education and Research, Shirpur, Dhule, 425405, MS, India

    Amod S. Patil, Anand B. Mundada, Ravindra S. Shravane, Pooja A. Mundada & Sanjay J. Surana

Authors
  1. Amod S. Patil
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Anand B. Mundada
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Ravindra S. Shravane
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Pooja A. Mundada
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Sanjay J. Surana
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Anand B. Mundada.

Ethics declarations

Conflict of interest

The authors declare that there are no conflicts of interest.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Patil, A.S., Mundada, A.B., Shravane, R.S. et al. Normal- and reversed-phase high-performance thin-layer chromatography methods for the simultaneous determination of remogliflozin etabonate and metformin hydrochloride antidiabetic drugs in bulk and tablet formulation. JPC-J Planar Chromat 36, 89–97 (2023). https://doi.org/10.1007/s00764-023-00229-0

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00764-023-00229-0

Keywords

Search

Navigation