Skip to main content

Advertisement

SpringerLink
Log in

Development and Validation of Rapid Stability-Indicating RP-HPLC Method for Assay and Related Substances of Solifenacin Succinate

  • Original
  • Published:
Chromatographia Aims and scope Submit manuscript

Abstract

A simple, inexpensive, rapid and novel stability-indicating reversed-phase high-performance liquid chromatographic method employing Zorbax-CN column has been developed and validated for the determination of both, assay and related substances of Solifenacin Succinate (SOL) drug substance and in its drug product. Forced degradation study of SOL was performed at acid, base, oxidative, photolytic and thermal stress conditions. Significant degradation was observed only in acidic and basic conditions. Four process and degradation impurities and have been identified by LC–MS and characterized by 1H NMR and FT-IR spectroscopy. The baseline separation of the impurities was achieved by gradient elution using phosphate buffer (pH 3.5) and a mixture of solvents (acetonitrile, methanol, and water), as mobile phase at a flow rate of 1.0 mL min−1. All impurities were quantified using a photodiode array detector (PDA) at 220 nm. The developed RP-HPLC method was validated in agreement with ICH requirements. The forced degradation studies proved the stability-indicating power of the method and hence, the validated method is useful for the intended use in routine analysis of SOL as bulk drug and in respective dosage forms. The salient feature of the presented method could be applied for assay and related substances determination of SOL in pharmaceutical laboratories and industries.

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.

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

Similar content being viewed by others

References

  1. Staskin DR, Trabu S (2009) Pharmacokinetics of overactive bladder drugs: Getting ahead of the curve. Curr Bladder Dysfunct Rep. 4:34–43

    Article  Google Scholar 

  2. Basra R, Kelleher C (2008) A review of SOL in the treatment of urinary incontinence. Ther Clin Risk Manag 4(1):117–128

    CAS  PubMed  PubMed Central  Google Scholar 

  3. https://en.wikipedia.org/wiki/Solifenacin-succinate

  4. https://drugs.com/monograph/solifenacin-succinate.html

  5. Oki T, Sato S, Miyata K, Yamada S (2005) Muscarinic receptor binding, plasma concentration and inhibition of salivation after oral administration of a noval antimuscarinic agent, Solifenacin succinate in mice. Br J Pharmacol 145(2):219–227

    Article  CAS  Google Scholar 

  6. Cardozo L, Lisec M, Lisec M (2004) Randomized, double-blind placebo controlled trial of the once daily antimuscarinic agent Solifenacin succinate in patients with overactive bladder. J Urol 172(5):1919–1924

    Article  CAS  Google Scholar 

  7. Maniscalco M, Singh-Franco D, Wolowich WR, Torres-Colón R (2006) Solifenacin succinate for the treatment of symptoms of overactive bladder. Clin Ther 28(9):1247–1272

    Article  CAS  Google Scholar 

  8. Kobayashi S, Ikeda K, Miyata K (2004) Comparison of in vitro selectivity profiles of Solifenacin succinate (YM905) and current antimuscarinic drugs in bladder and salivary glands: a Ca2+ mobilization study in monkey cells. Life Sci 74(7):843–853

    Article  CAS  Google Scholar 

  9. Hegde SS (2006) Muscarinic receptors in the bladder: from basic research of therapeutics. Br J Pharmacol 147:S80–S87

    Article  CAS  Google Scholar 

  10. Chase TN, Farlow MR, Clarence-Smith K (2017) Donepezil plus Solifenacin succinate (CPC-201) treatment for alzheimer’s disease. Neurotherapeutics 14(2):405–416

    Article  CAS  Google Scholar 

  11. Smulders RA, Krauwinkel WJ, Swart PJ, Huang M (2004) Pharmacokinetics and safety of SOL in healthy young men. J Clin Pharmacol 44:1023–1033

    Article  CAS  Google Scholar 

  12. Wagg A, Wyndaele JJ, Sieber P (2006) Efficacy and tolerability of Solifenacin succinate in elderly subjects with overactive bladder syndrome: a pooled analysis. Am J Geriatr Pharmacother 4(1):14–24

    Article  CAS  Google Scholar 

  13. Naito R, Yonetoku Y, Okamoto Y, Toyoshima A, Ikeda K, Takeuchi M (2005) Synthesis and antimuscarinic properties of quinuclidin-3-yl 1,2,3,4-tetrahydroisoquinoline-2-carboxylate derivatives as novel muscarinic receptor antagonists. J Med Chem 48(21):6597–6606

    Article  CAS  Google Scholar 

  14. Metello J, Nogueira B, Torgal M, Colaco J, Vieira A, Goncalves V, Retto H (2007) Comparison of the efficacy and tolerability of Solifenacin succinate with or previous use of trospiun chloride. Int Urogynecol J 18:1021–1025

    Article  CAS  Google Scholar 

  15. Doroshyenko O, Fuhr U (2009) Clinical pharmacokinetics and pharmacodynamics of Solifenacin succinate. Clin Pharmacokinet 48(5):281–302

    Article  CAS  Google Scholar 

  16. Landge SB, Jadhav S, Dahale S, Niphade N, Narayana C, Gaikwad V, Mathad VT (2011) Development and validation of new chromatographic method for the determination of enantiomeric and diastereomeric purity of Solifenacin succinate: an antimuscarinic agent. Chromatogr Resear Inter 243491:7

    Google Scholar 

  17. Reddy Ganthi HK, Ravindra Reddy P, Park YJ, Reddy Bapatu H, Park SJ, Cho WH (2016) Stability indicating HPLC method for quantification of Solifenacin succinate and Tamsulosin hydrochloride along with its impurities in tablet dosage form. Am J Anal Chem 7:840–872

    Article  Google Scholar 

  18. Yanagihara T, Aoki T, Soeishi Y, Iwatsubo T, Kamimur H (2007) Determination of Solifenacin succinate, a novel muscarinic receptor antagonist, and its major metabolite in rat plasma by semi-micro high performance liquid chromatography. J Chromatogr B 859(2):241–245

    Article  CAS  Google Scholar 

  19. Rami Reddy BV, Srinivasa Reddy B, Raman N, Subhash Reddy K, Rambabu C (2013) Development and validation of a specific stability indicating high performance liquid chromatographic methods for related compounds and assay of Solifenacin succinate. J Chem 1:412353

    Google Scholar 

  20. Desai D, Patel G, Shukla N, Rajput S (2012) Development and validation of stability indicating HPLC method for Solifenacin succinate: Isolation and identification of major base degradation product. Acta Chromatogr 24(3):399–418

    Article  CAS  Google Scholar 

  21. Radha Krishna S, Rao BM, Someswara Rao N (2010) A validated rapid stability- indicating method for the determination of related substances in Solifenacin succinate by ultra-Fast liquid chromatography. J Chromatogr Sci 48:807–810

    Article  Google Scholar 

  22. Singh DK, Kurmi M, Handa T, Singh S (2016) LC-MS/TOF, LC-MSn and HD exchange studies on Solifenacin succinate targeted to characterize its force degradation product. Chromatographia 79:159–168

    Article  CAS  Google Scholar 

  23. The European pharmacopeia 8.6, Monographs 2779 (2016), pp 5384–5386.

  24. The United States Pharmacopeia, Validation of Compendial Methods, 2017, 35nd edn. (USP 40), Section < 1225 >

  25. International conference on harmonization November (2005) Guidance for industry text and methodology on validation of analytical procedure Q2 (R1).

  26. International conference on harmonization November (1996), Photo stability testing of new drug substances and products—Q1B.

  27. Bakshi M, Singh S (2002) Development of validated stability indicating assay methods critical review. J Pharm Biomed Anal 28:1011–1040

    Article  CAS  Google Scholar 

  28. LoBrutto R, Jones A, Kazakevich YV, McNair HM (2001) Effect of the eluent pH and acidic modifiers in high-performance liquid chromatography retention of basic analytes. J Chromatogr A 913(1–2):173–187

    Article  CAS  Google Scholar 

Download references

Acknowledgements

Authors thank the management of Credence Fine Chem and Wockhardt ltd group for their support. They are also thankful to colleagues of division of Research and Development of Deogiri College, Aurangabad for their cooperation.

Funding

None.

Author information

Authors and Affiliations

  1. Wockhardt Research Centre, D-4, MIDC, Chikalthana, Aurangabad, 431006, India

    Rajiv A. Jadhav

  2. Department of Chemistry, Deogiri College, Aurangabad, 431005, India

    Rajiv A. Jadhav, Yogeesha M. Sanil, Sunil G. Shankarwar, Anil G. Shankarwar, Rajendra P. Pawar & Saroj R. Bembalkar

Authors
  1. Rajiv A. Jadhav
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Yogeesha M. Sanil
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Sunil G. Shankarwar
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Anil G. Shankarwar
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Rajendra P. Pawar
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Saroj R. Bembalkar
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Saroj R. Bembalkar.

Ethics declarations

Human and Animal Rights

This article does not contain any studies with human participants or animals performed by any of the authors.

Conflict of Interest

The authors declare that there is no conflict regarding publication of this manuscript.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Jadhav, R.A., Sanil, Y.M., Shankarwar, S.G. et al. Development and Validation of Rapid Stability-Indicating RP-HPLC Method for Assay and Related Substances of Solifenacin Succinate. Chromatographia 83, 1107–1119 (2020). https://doi.org/10.1007/s10337-020-03929-5

Download citation

  • Received:

  • Revised:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10337-020-03929-5

Keywords

Search

Navigation