Skip to main content
SpringerLink
Log in

New Stability Indicating RP-UPLC Method for Simultaneous Estimation of Telmisartan and Azelnidipine in Bulk and Combined Bilayer Film-Coated Tablet Dosage Form

  • Published:
Pharmaceutical Chemistry Journal Aims and scope

An efficient, perceptive, sensitive, accurate and economical RP-UPLC method with tunable UV detector has been developed for the simultaneous estimation of telmisartan and azelnidipine in bulk powders and their combined film-coated bilayer tablet dosage form. The proposed method employs Agilent Zorbax Stable Bond (SB) packing C8 (100 mm × 2.1 mm, 2 μm) column, a mobile phase consisting of 0.01 N potassium dihydrogen orthophosphate (pH 4.8) and acetonitrile in 70:30 v/v ratio pumped at a flow rate of 0.3 mL/min, and the UV detector tuned to 257 nm wavelength, which reliably separates all analytes with good resolution. Telmisartan and azelnidipine were eluted from the column at 0.675 and 1.601 min, respectively. Linearity of the telmisartan and azelnidipine determination was observed in the range of 20 – 120 μg/mL and 2 – 12 μg/mL, respectively. Computed values of the validation parameters confidently show that the method is specific, accurate and precise with high sensitivity. Exploration of the analytes under various forced degradation conditions with the help of the proposed method confirms stability-indicating character of the method. The developed method has high efficiency in separating telmisartan and azelnidipine and ensures their stability-indicating assay with good sensitivity and specificity, thus being adapted to the pharmaceutical industry applications.

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.

Similar content being viewed by others

References

  1. P. Gosse, Vasc. Health Risk Manag., 2, 195 – 201 (2006).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  2. W. Wienen, M. Entzeroth, J. C. A. V. Meel, et al., Cardiovasc. Drug Rev., 18, 127 – 154 (2000).

    Article  CAS  Google Scholar 

  3. S. Nandi, S. Nag, T. Ash, et al., Med. Res. Chronicles, 7, 366 – 370 (2020).

    Article  Google Scholar 

  4. G. Guido, Q. T. Fosca, and M. Giuseppe, J. Renin Angiotensin Aldosterone Syst., 9, 66 – 74 (2008).

    Article  Google Scholar 

  5. K. Shimada, K. Miyauchi, and H. Daida, Expert Rev. Cardiovasc. Ther., 13, 23 – 31 (2015).

    Article  CAS  PubMed  Google Scholar 

  6. M. Watanabe, T. Hirano, S. Okamoto, et al., Hypertens. Res., 33, 43 – 48 (2010).

    Article  CAS  PubMed  Google Scholar 

  7. V. U. Shewale, S. S. Aher, and R. B. Saudagar, J. Drug Deliv. Ther., 9, 1002 – 1005 (2019).

    CAS  Google Scholar 

  8. B. Upendra, H. Dhaked, and A. K. Danodia, Int. J. Drug Regul. Aff., 1, 61 – 64 (2013).

    Google Scholar 

  9. P. Ashok, S. T. Narenderan, S. N. Meyyanathan, et al., Int. J. Appl. Pharm., 237 – 240 (2019).

  10. V. P. Kurade, M. G. Pai, and R. Gude, Indian J. Pharm. Sci., 71, 148 – 151 (2009).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. S. Shaina, S. Varinder, R. Sandeep, et al., J. Pharm. Technol. Res. Manag., 4, 63 – 79 (2016).

    Article  Google Scholar 

  12. N. Doshi, A. Sheth, A. Sharma, et al., J. Chem. Pharm. Res., 2, 252 – 263 (2010).

    CAS  Google Scholar 

  13. V. U. Barge, R. B. Gaikwad, F. M. Chaudhari, et al., Int. J. Pharm. Clin. Res., 10, 219 – 223 (2018).

    Google Scholar 

  14. A. R. Chabukswar, S. C. Jagdale, S. V. Kumbhar, et al., Res. J. Pharm. Technol., 3, 1227 – 1230 (2010).

    CAS  Google Scholar 

  15. M. L. Surekha, G. K. Swamy, and G. L. Ashwini, Int. J. Drug Dev. Res., 4, 200 – 205 (2012).

    Google Scholar 

  16. S. V. Prasad, G. P. Satish, and V. M. Kiran, J. Anal. Bioanal. Tech., 03 (2012).

  17. A. K. Palakurthi, T. Dongala, and L. N. R. Katakam, Pract. Lab. Med., 21 (2020).

  18. S. Nalwade, V. Ranga Reddy, D. Durga Rao, et al., Sci. Pharm., 79, 69 – 84 (2011).

  19. V. B. Ravi, J. K. Inamadugu, N. R. Pilli, et al., J. Pharm. Anal., 2, 319 – 326 (2012).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  20. P. Sengupta, B. Chatterjee, U. K. Mandal, et al., J. Pharm. Anal., 7, 381 – 387 (2017).

    Article  PubMed  PubMed Central  Google Scholar 

  21. K. D. Raskapur, M. P. Mrunali, and D. C. Anandkumari, Int. J. Pharm. Pharm. Sci., 4, 238 – 240 (2011).

    Google Scholar 

  22. S. Muralidharan, S. Parasuraman, and V. Venugopal, J. Pharm. Belg., 1, 43 – 45 (2015).

    CAS  Google Scholar 

  23. D. Prabhakar, J. Sreekanth, and K. N. Jayaveera, Int. J. Chemtech Res., 11,7 – 12 (2018).

    CAS  Google Scholar 

  24. K. P. Jayvadan and K. P. Nilam, Sci. Pharm., 82, 541 – 554 (2014).

    Article  Google Scholar 

  25. K. Manish, Umesh Chandra, G. Pankaj, et al., Int. J. Pharm. Sci. Drug Res., 13 (2021).

  26. K. Kishore and K. Somasekhar Reddy, Bull. Env. Pharmacol. Life Sci., 10, 19 – 27 (2021).

  27. International Council for Harmonisation (ICH). Quality Guidelines ICH. https://www.ich.org/page/quality-guidelines (accessed January 18, 2021).

  28. Analytical Procedures and Methods Validation for Drugs and Biologics, Analytical Procedures: Guidance for Industry, U. S. Department of Health and Human Services Food and Drug Administration (2015).

  29. M. Blessy, R. D. Patel, P. N. Prajapati, et al., J. Pharm. Anal., 4, 159 – 165 (2014).

    Article  CAS  PubMed  Google Scholar 

  30. K. K. Otha, S. P. K. Reddy, V. K. Raju, et al., Int. Res. J. Pharm., 4, 78 – 85 (2013).

    Google Scholar 

  31. G. Ngwa, Drug Deliv. Technol., 10, 56 – 59 (2010).

    CAS  Google Scholar 

  32. British Pharmacopoeia (BP) 2016, https://www.pharmacopoeia.com/the-british-pharmacopoeia (accessed January 27, 2021).

Download references

Acknowledgments

The authors are thankful to the Department of Pharmaceutical Analysis, Sri Padmavati Mahila Visvavidyalayam (Tirupati Andhrapradesh, India) for encouragement.

Competing Interest

The authors declare that they have no conflicts of interest.

Authors’ Contributions

All authors contributed equally in design of the work and corresponding author played vital role in manuscript preparation. All authors have read and approved the manuscript.

Author information

Authors and Affiliations

  1. Department of Pharmaceutical Analysis, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam, Tirupati, Andhrapradesh, 517501, India

    Addanki Swetha

  2. Department of Pharmacognosy, Institute of Pharmaceutical Technology, Sri Padmavati Mahila Visvavidyalayam, Tirupati, Andhrapradesh, 517501, India

    Kuber B. Ramya

Authors
  1. Addanki Swetha
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Kuber B. Ramya
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kuber B. Ramya.

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

Swetha, A., Ramya, K.B. New Stability Indicating RP-UPLC Method for Simultaneous Estimation of Telmisartan and Azelnidipine in Bulk and Combined Bilayer Film-Coated Tablet Dosage Form. Pharm Chem J 56, 1544–1551 (2023). https://doi.org/10.1007/s11094-023-02826-z

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11094-023-02826-z

Keywords

Search

Navigation