Skip to main content
SpringerLink
Log in

A design of experiment based RP-HPLC method for the simultaneous estimation of antihypertensive drugs with greenness assessment

  • Original Paper
  • Published:
Analytical Sciences Aims and scope Submit manuscript

Abstract

The correlation between blood pressure (BP) and cardiovascular risk has a continuous, positive, and linear pattern. Lowering high BP decreases the risk associated with cardiovascular disease. Chlorthalidone (CHD) and Losartan potassium (LOS) combination is used to treat hypertension. The analytical community was concerned with minimizing or reducing the use of toxic chemicals and solvents. Therefore, the current study aimed to develop a rapid, sensitive, and cost-effective green RP-HPLC method to determine CHD and LOS simultaneously in a short analysis of time. Method optimization was performed by Central composite design (CCD), the flow rate and the change of time were chosen as factors. Effective separation was conducted on Zorbax SB-C18 (4.6 mm \(\times\) 150 mm, 5 μm) column by gradient mobile phase comprising phosphate buffer and ethanol flowing at 0.859 ml/min, and the wavelength detected at 230 nm. As per ICH criteria, the technique was proven to be precise, accurate, and linear over the concentration range of 4.3–8.1 μg/ml for CHD and 35–65 μg/ml for LOS. Furthermore, the method’s greenness was examined by three different metrics, confirming that less toxic effect on the environment. Hence, the optimized approach proves to be eco-friendly, simple, and robust for the concurrent evaluation of CHD and LOS in pharmaceutical formulations.

Graphical abstract

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
Fig. 6
Fig. 7

Similar content being viewed by others

Data availability

Authors declare that all the data necessary to support the findings of this study are included in the article.

References

  1. E. Adeyeye, V. Kapil, M.D. Lobo, Hypertension. Medicine (Baltimore) 50, 399–407 (2022). https://doi.org/10.1016/j.mpmed.2022.04.002

    Article  Google Scholar 

  2. C. Cuspidi, M. Tadic, G. Grassi, G. Mancia, Treatment of hypertension: the ESH/ESC guidelines recommendations. Pharmacol. Res. 128, 315–321 (2018). https://doi.org/10.1016/j.phrs.2017.10.003

    Article  PubMed  Google Scholar 

  3. G. Bakris, W. Ali, G. Parati, ACC/AHA versus ESC/ESH on hypertension guidelines: JACC guideline comparison. J. Am. Coll. Cardiol. 73, 3018–3026 (2019). https://doi.org/10.1016/j.jacc.2019.03.507

    Article  PubMed  Google Scholar 

  4. B.L. Carter, M.E. Ernst, J.D. Cohen, Hydrochlorothiazide versus chlorthalidone: evidence supporting their interchangeability. Hypertension 43, 4–9 (2004). https://doi.org/10.1161/01.HYP.0000103632.19915.0E

    Article  CAS  PubMed  Google Scholar 

  5. D.A. Sica, B. Carter, W. Cushman, L. Hamm, Thiazide and loop diuretics. J. Clin. Hypertens. 13, 639–643 (2011). https://doi.org/10.1111/j.1751-7176.2011.00512.x

    Article  CAS  Google Scholar 

  6. S.M. Ibrahim, M.A. El-didamoony, M.E. Elsadek, M.M. Baraka, M.M. Sebaiy, Analytical methods for determination of certain antihypertensive drugs. Biomed J Sci Tech Res. 34(2), 26511–26527 (2021). https://doi.org/10.26717/BJSTR.2021.34.005513

    Article  Google Scholar 

  7. R.D. Smith, A.T. Chiu, P.C. Wong, W.F. Herblin, P.B.M.W.M. Timmermans, pharmacology of nonpeptide angiotensin ii receptor ant agonists. Annu. Rev. Pharmacal. Toxicol. 32, 135–6532 (1992)

    Article  CAS  Google Scholar 

  8. V. Sukumar, H.K. Chanduluru, S. Chinnusamy, Ecofriendly analytical quality by design-based method for determining metronidazole, lidocaine and miconazole using RP-HPLC in semisolid dosage form. J. Taibah Univ. Sci. 17(1), 1–10 (2023). https://doi.org/10.1080/16583655.2023.2252593

    Article  Google Scholar 

  9. M. Yabre, L. Ferey, I.T. Somé, K. Gaudin, Greening reversed-phase liquid chromatography methods using alternative solvents for pharmaceutical analysis. Molecules (2018). https://doi.org/10.3390/molecules23051065

    Article  PubMed  PubMed Central  Google Scholar 

  10. A. Gałuszka, Z. Migaszewski, J. Namieśnik, The 12 principles of green analytical chemistry and the SIGNIFICANCE mnemonic of green analytical practices, TrAC -. Trends Anal. Chem. 50, 78–84 (2013). https://doi.org/10.1016/j.trac.2013.04.010

    Article  CAS  Google Scholar 

  11. C.J. Welch, N. Wu, M. Biba, R. Hartman, T. Brkovic, X. Gong, R. Helmy, W. Schafer, J. Cuff, Z. Pirzada, L. Zhou, Greening analytical chromatography. TrAC - Trends Anal. Chem. 29(7), 667–680 (2010). https://doi.org/10.1016/j.trac.2010.03.008

    Article  CAS  Google Scholar 

  12. M. Koel, Do we need green analytical chemistry? Green Chem. 18, 923–931 (2016). https://doi.org/10.1039/c5gc02156a

    Article  CAS  Google Scholar 

  13. K.S. Kokilambigai, K.S. Lakshmi, Analytical quality by design assisted RP-HPLC method for quantifying atorvastatin with green analytical chemistry perspective. J. Chromatogr. Open. 2, 100052 (2022). https://doi.org/10.1016/j.jcoa.2022.100052

    Article  Google Scholar 

  14. M.S. Imam, A.S. Batubara, M. Gamal, A.H. Abdelazim, A.A. Almrasy, S. Ramzy, Adjusted green HPLC determination of nirmatrelvir and ritonavir in the new FDA approved co-packaged pharmaceutical dosage using supported computational calculations. Sci. Rep. 13, 137 (2023). https://doi.org/10.1038/s41598-022-26944-y

    Article  ADS  CAS  PubMed  PubMed Central  Google Scholar 

  15. T. Verch, C. Campa, C.C. Chéry, R. Frenkel, T. Graul, N. Jaya, B. Nakhle, J. Springall, J. Starkey, J. Wypych, T. Ranheim, Analytical quality by design, life cycle management, and method control. AAPS J. 24, 1–21 (2022). https://doi.org/10.1208/s12248-022-00685-2

    Article  Google Scholar 

  16. R. Peraman, K. Bhadraya, Y.R. Padmanabha, Analytical quality by design a tool for regulatory flexibility and robust analytics. Int J Anal Chem (2015). https://doi.org/10.1155/2015/868727

    Article  PubMed  PubMed Central  Google Scholar 

  17. K. Monks, I. Molnár, H.J. Rieger, B. Bogáti, E. Szabó, Quality by design: Multidimensional exploration of the design space in high performance liquid chromatography method development for better robustness before validation. J. Chromatogr. A 1232, 218–230 (2012). https://doi.org/10.1016/j.chroma.2011.12.041

    Article  CAS  PubMed  Google Scholar 

  18. ICH, Q14: analytical procedure development (draft version), (2022) 1–64. https://www.teses.usp.br/teses/disponiveis/11/11132/tde-20200111-131624/publico/ParreJoseLuiz.pdf.

  19. D. Nagavalli, J. Jayanthi, P. Nanthagopal, Simultaneous estimation of losartan potassium and chlorthalidone in tablets by RP-HPLC method. IJCRT 11(3), 471–481 (2023)

    Google Scholar 

  20. M.A. Hinge, V.M. Bhanusali, R.J. Mahida, Spectrophotometric and high performance liquid chromatographic determination of chlorthalidone and losartan potassium in combined dosage form. Anal. Chem. Lett. 6(4), 408–420 (2016). https://doi.org/10.1080/22297928.2016.1206834

    Article  CAS  Google Scholar 

  21. T.P. Anessh, R. Radhakrishnan, P.M. Aravind, A. Sasidharan, M. Choyal, Rp-Hplc method for Simultaneous determination of losartan and chlorthalidone in pharmaceutical dosage form. Int. Res. J. Pharm. 6(7), 453–457 (2015). https://doi.org/10.7897/2230-8407.06793

    Article  CAS  Google Scholar 

  22. H. Hashem, H.M. El-Sayed, Quality by design approach for development and validation of a RP-HPLC method for simultaneous determination of co-administered levetiracetam and pyridoxine HCl in prepared tablets. Microchem. J. 143, 55–63 (2018). https://doi.org/10.1016/j.microc.2018.07.031

    Article  CAS  Google Scholar 

  23. J. Płotka-Wasylka, A new tool for the evaluation of the analytical procedure: green analytical procedure index. Talanta 181, 204–209 (2018). https://doi.org/10.1016/j.talanta.2018.01.013

    Article  CAS  PubMed  Google Scholar 

  24. K. Parvathi, A. Sugumaran, H. Kumar, Simultaneous estimation of crotamiton and hydrocortisone by RP-UPLC using green analytical principles embedded analytical quality by design ( AQbD ) method. Microchem. J. 184, 108166 (2023). https://doi.org/10.1016/j.microc.2022.108166

    Article  CAS  Google Scholar 

  25. H.M. Mohamed, N.T. Lamie, Analytical eco-scale for assessing the greenness of a developed RP-HPLC method used for simultaneous analysis of combined antihypertensive medications. J. AOAC Int. 99(5), 1260–1265 (2016). https://doi.org/10.5740/jaoacint.16-0124

    Article  CAS  PubMed  Google Scholar 

  26. F. Pena-Pereira, W. Wojnowski, M. Tobiszewski, AGREE - analytical GREEnness metric approach and software. Anal. Chem. 92, 10076–10082 (2020). https://doi.org/10.1021/acs.analchem.0c01887

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  27. A.J.A. Ahmed, K. Kammoun, M.T.A. Khayat, R.M. Youssef, Development of validated methods for the simultaneous quantification of Finasteride and Tadalafil in newly launched FDA-approved therapeutic combination: greenness assessment using AGP, analytical eco-scale, and GAPI tools. RSC Adv. 13, 11817–11825 (2023). https://doi.org/10.1039/d3ra01437a

    Article  ADS  CAS  Google Scholar 

  28. S. Rathinam, L.K. Santhana, Analytical quality by design approach for estimating rosuvastatin calcium in pharmaceutical formulation by green HPLC method: ecologically evaluated and stability-indicating. J. Appl. Pharm. Sci. 11(11), 150–160 (2021). https://doi.org/10.7324/JAPS.2021.1101119

    Article  CAS  Google Scholar 

  29. V. Sukumar, S. Chinnusamy, H.K. Chanduluru, S. Rathinam, Method development and validation of atorvastatin, ezetimibe and fenofibrate using RP-HPLC along with their forced degradation studies and greenness profiling. Green Chem. Lett. Rev. (2023). https://doi.org/10.1080/17518253.2023.2198651

    Article  Google Scholar 

  30. M. Blessy, R.D. Patel, P.N. Prajapati, Y.K. Agrawal, Development of forced degradation and stability indicating studies of drugs – a review. J. Pharm. Anal. 4(3), 159–165 (2014). https://doi.org/10.1016/j.jpha.2013.09.003

    Article  CAS  PubMed  Google Scholar 

  31. K.P. Kannaiah, A. Sugumaran, H.K. Chanduluru, S. Rathinam, Environmental impact of greenness assessment tools in liquid chromatography – a review. Microchem. J. 170, 106685 (2021). https://doi.org/10.1016/j.microc.2021.106685

    Article  CAS  Google Scholar 

  32. H.K. Chanduluru, A. Sugumaran, Assessment of greenness for the determination of voriconazole in reported analytical method. RSC Adv. 12, 6683–6703 (2022). https://doi.org/10.1039/D1RA08858K

    Article  ADS  CAS  PubMed  PubMed Central  Google Scholar 

  33. M.A. Korany, H. Mahgoub, R.S. Haggag, M.A.A. Ragab, O.A. Elmallah, Green chemistry: analytical and chromatography. J. Liq. Chromatogr. Relat. Technol. 40, 839–852 (2017). https://doi.org/10.1080/10826076.2017.1373672

    Article  CAS  Google Scholar 

Download references

Acknowledgements

The authors are grateful to SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, for their encouragement and support to conduct this research.

Author information

Authors and Affiliations

  1. Department of Pharmaceutical Analysis, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chennai, 603203, India

    Naveenarani Dharuman, Lakshmi Karunanidhi Santhana & Manikandan Krishnan

Authors
  1. Naveenarani Dharuman
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Lakshmi Karunanidhi Santhana
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Manikandan Krishnan
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Lakshmi Karunanidhi Santhana.

Ethics declarations

Conflict of interest

No potential conflict of interest was reported by the author(s).

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

Dharuman, N., Karunanidhi Santhana, L. & Krishnan, M. A design of experiment based RP-HPLC method for the simultaneous estimation of antihypertensive drugs with greenness assessment. ANAL. SCI. (2024). https://doi.org/10.1007/s44211-024-00538-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • DOI: https://doi.org/10.1007/s44211-024-00538-2

Keywords

Search

Navigation