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Development of the HPLC Method for Simultaneous Determination of Lidocaine Hydrochloride and Tribenoside Along with Their Impurities Supported by the QSRR Approach

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Abstract

A new liquid chromatographic (LC) method for simultaneous determination of lidocaine hydrochloride (LH) and tribenoside (TR) along with their related compounds in pharmaceutical preparations is described. Satisfactory LC separation of all analytes after the liquid–liquid extraction (LLE) procedure with ethanol was performed on a C18 column using a gradient elution of a mixture of acetonitrile and 0.1 % orthophosphoric acid as the mobile phase. The procedure was validated according to the ICH guidelines. The limits of detection (LOD) and quantification (LOQ) were 4.36 and 13.21 μg mL−1 for LH, 7.60 and 23.04 μg mL−1 for TR, and below 0.11 and 0.33 μg mL−1 for their impurities, respectively. Intra- and inter-day precision was below 1.97 %, whereas accuracy for all analytes ranged from 98.17 to 101.94 %. The proposed method was sensitive, robust, and specific allowing reliable simultaneous quantification of all mentioned compounds. Moreover, a comparative study of the RP-LC column classification based on the quantitative structure-retention relationships (QSRR) and column selectivity obtained in real pharmaceutical analysis was innovatively applied using factor analysis (FA). In the column performance test, the analysis of LH and TR in the presence of their impurities was carried out according to the developed method with the use of 12 RP-LC stationary phases previously tested under the QSRR conditions. The obtained results confirmed that the classes of the stationary phases selected in accordance with the QSRR models provided comparable separation for LH, TR, and their impurities. Hence, it was concluded that the proposed QSRR approach could be considered a supportive tool in the selection of the suitable column for the pharmaceutical analysis.

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References

  1. (2011) European Pharmacopoeia, 7th edn. Council of Europe, Strasbourg, France

  2. (2011) Her majesty’s stationary office. In: British Pharmacopeia, UK, London

  3. Escuder-Gilabert L, Sagrado S, Villanueva-Camafias RM, Medina-Hernandez MJ (1999) Chromatographia 49:85–90

    Article  CAS  Google Scholar 

  4. Baczyński E, Piwońska A, Fijałek Z (2002) Acta Pol Pharm—Drug Res 59:333–339

    Google Scholar 

  5. Fijałek Z, Baczyński E, Piwońska A, Warowna-Grześkiewicz M (2005) J Pharm Biomed Anal 37:913–918

    Article  Google Scholar 

  6. Salas S, Talero B, Rabasco AM, González-Rodríguez ML (2008) J Pharm Biomed Anal 47:501–507

    Article  CAS  Google Scholar 

  7. Zivanovic L, Zecevic M, Markovic S, Petrovic S, Ivanovic I (2005) J Chromatogr A 1088:182–186

    Article  CAS  Google Scholar 

  8. Wiberg K, Jacobsson SP (2004) Anal Chim Acta 514:203–209

    Article  CAS  Google Scholar 

  9. Abdul-Azim Mohammad M (2009) Chromatographia 70:563–568

    Article  Google Scholar 

  10. Smith DJ (1981) J Chromatogr Sci 19:253–258

    Article  CAS  Google Scholar 

  11. Abdel-Rehim M, Bielenstein M, Askemark Y, Tyrefors N, Arvidsson T (2000) J Chromatogr B 741:175–188

    Article  CAS  Google Scholar 

  12. Song L, Zhang D (2005) Chin Pharmaceut J 40:1102–1104

    CAS  Google Scholar 

  13. Sioufi A, Pommier F (1980) J Pharm Sci 69:167–169

    Article  CAS  Google Scholar 

  14. Vachek J (1985) Cesk Farm 34:420–421

    CAS  Google Scholar 

  15. Claessens HA, van Straten MA, Cramers CA, Jezierska M, Buszewski B (1998) J Chromatogr A 826:135–156

    Article  CAS  Google Scholar 

  16. Wilson NS, Nelson MD, Dolan JW, Snyder LR, Carr PW, Sander LC (2002) J Chromatogr A 961:217–236

    Article  CAS  Google Scholar 

  17. Cruz E, Euerby MR, Johnson CM, Hackett CA (1997) Chromatographia 44:151–161

    Article  CAS  Google Scholar 

  18. Andries JPM, Claessens HA, Vander Heyden Y, Buydens LMC (2009) Anal Chim Acta 652:180–188

    Article  CAS  Google Scholar 

  19. Héberger K (2010) Trends Anal Chem 29:101–109

    Article  Google Scholar 

  20. Dragovic S, Haghedooren E, Nemeth T, Palabiyik IM, Hoogmartens J, Adams E (2009) J Chromatogr A 1216:3210–3216

    Article  CAS  Google Scholar 

  21. Szulfer J, Plenis A, Bączek T (2012) J Chromatogr A 1229:198–207

    Article  CAS  Google Scholar 

  22. Szulfer J, Plenis A, Bączek T (2012) Talanta 99:492–501

    Article  CAS  Google Scholar 

  23. Bączek T, Kaliszan R (2003) J Chromatogr A 987:29–37

    Article  Google Scholar 

  24. Bączek T, Bodzioch K, Michalska E, Kaliszan R (2008) Chromatographia 68:161–166

    Article  Google Scholar 

  25. Bączek T, Kaliszan R, Novotńa K, Jandera P (2005) J Chromatogr A 1075:109–115

    Article  Google Scholar 

  26. Kaliszan R, van Straten MA, Markuszewski M, Cramers CA, Claessens HA (1999) J Chromatogr A 855: 455–486

    Google Scholar 

  27. Bączek T, Kaliszan R (2002) J Chromatogr A 962:41–55

    Article  Google Scholar 

  28. Plenis A, Balakowska E, Bączek T (2011) J Sep Sci 34:3310–3321

    Article  CAS  Google Scholar 

  29. (1996) ICH note for guidelines on validation of analytical procedures: text and methodology (Q2R1), IFPMA, Switzerland

Download references

Acknowledgments

The work was supported by the Polish State Committee for Scientific Research Projects N N405 024340.

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This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

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Authors and Affiliations

  1. Department of Pharmaceutical Chemistry, Medical University of Gdańsk, Hallera 107, 80-416, Gdańsk, Poland

    Alina Plenis, Lucyna Konieczna, Natalia Miękus & Tomasz Bączek

Authors
  1. Alina Plenis
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  2. Lucyna Konieczna
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  3. Natalia Miękus
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  4. Tomasz Bączek
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Corresponding author

Correspondence to Tomasz Bączek.

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Published in the topical collection Chemometrics in Chromatography with guest editors B. Jančić-Stojanović and Y. Dotsikas.

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Plenis, A., Konieczna, L., Miękus, N. et al. Development of the HPLC Method for Simultaneous Determination of Lidocaine Hydrochloride and Tribenoside Along with Their Impurities Supported by the QSRR Approach. Chromatographia 76, 255–265 (2013). https://doi.org/10.1007/s10337-012-2339-9

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  • DOI: https://doi.org/10.1007/s10337-012-2339-9

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