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Chromatographia

, Volume 67, Issue 7–8, pp 517–525 | Cite as

Simultaneous Determination of Metformin Hydrochloride, Cyanoguanidine and Melamine in Tablets by Mixed-Mode HILIC

  • Mohammed Shahid Ali
  • Syed Rafiuddin
  • Mohsin Ghori
  • Aamer Roshanali Khatri
Original

Abstract

A simple and specific hydrophilic interaction liquid chromatography (HILIC) procedure for the quantification of metformin hydrochloride (MFH) and its impurities in bulk pharmaceuticals and finished dosage forms has been developed. The method is based on hydrophilic interaction of the analytes with silica. The influence of the weaker solvent, acetonitrile, pH and the nature and ionic strength of the buffer was studied. Linearity range and percent recoveries for MFH were 100–400 μg mL−1 and 100.62%, respectively. Good validation data were obtained for all compounds. The method separates impurities cyanoguanidine (CGD), melamine (MLN) and other degradation products with a run time of less than 13 min. Degradation studies involved thermal stress, hydrolysis at various pHs and chemical and photolytic oxidation.

Keywords

Column liquid chromatography HILIC Metformin hydrochloride Melamine Cyanoguanidine Degradation studies 

Notes

Acknowledgments

Authors wish to thank Mr. Anwar Saeed, Mr. Mahmoud Yusuf Jamjoom and Mr. Noor Sheriff for encouraging this work and providing required support in accomplishing the proposed HILIC method.

References

  1. 1.
    USP 29 NF 24, United States Pharmacopoeia (2005) United States Pharmacopeial Convention, Inc., RockvilleGoogle Scholar
  2. 2.
    James Reynolds EF, Part I, Martindale, The Extra Pharmacopoeia (1996) 31st edn. Royal Pharmaceutical Society of Great Britain, LondonGoogle Scholar
  3. 3.
    BP’ 2005, British Pharmacopoeia (2005) The Stationary Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA), vol I–IIGoogle Scholar
  4. 4.
    Arayne MS, Sultana N, Zuberi MH (2006) Pak J Pharm Sci 19:231–235Google Scholar
  5. 5.
    Madhira BS, Vaibhav DM, Dimal AS, Kashyap KB, Rajendra SM, Madhira G, Binita JP (2005) J AOAC Int 88:1167–1172Google Scholar
  6. 6.
    Kolte BL, Raut BB, Deo AA, Bagool MA, Shinde DB (2004) J Chromatogr Sci 42:27–31Google Scholar
  7. 7.
    Ceren Y, Nuran Ö (2005) Anal Chim Acta 549:88–95CrossRefGoogle Scholar
  8. 8.
    Kolte BL, Raut BB, Deo AA, Bagool MA, Shinde DB (2004) J Chromatogr Sci 42:70–73Google Scholar
  9. 9.
    Vasudevan M, Ravi J, Ravisankar S, Suresh B (2001) J Pharm Biomed Anal 25:77–84CrossRefGoogle Scholar
  10. 10.
    Ghassempour A, Ahmadi M, Ebrahimi SN, Aboul-Enein HY (2006) Chromatographia 64:101–104CrossRefGoogle Scholar
  11. 11.
    Kolte BL, Raut BB, Deo AA, Bagool MA, Shinde DB (2006) Encyclopedia of Chromatography, Taylor & Francis, LondonGoogle Scholar
  12. 12.
    El-Khateeb SZ, Assaad HN, El-Bardicy MG, Ahmad AS (1998) Anal Chim Acta 208:321–324CrossRefGoogle Scholar
  13. 13.
    Habib IHI, Kamel MS (2003) Talanta 60:185–190CrossRefGoogle Scholar
  14. 14.
    Saad SMH, Wagiha HM, Mohamed AFE, Abdel Hammeed MO (1999) Anal Chim Acta 378:299–311CrossRefGoogle Scholar
  15. 15.
    Ashour S, Kabbani R (2003) Anal Lett 36:361–370CrossRefGoogle Scholar
  16. 16.
    El-bardicy MG, El-khateeb SZ, Abdelkader SA, Hoda NA (1989) Spectrosc Lett 22:1173–1181CrossRefGoogle Scholar
  17. 17.
    Wang LR, Huang MZ, Zhu SH (2005) Zhejiang Da Xue Xue Bao Yi Xue Ban 34:368–371Google Scholar
  18. 18.
    Victor D, Andrei M, Florin A (2005) J Liq Chromatogr Relat Technol 28:81–95CrossRefGoogle Scholar
  19. 19.
    ICH Harmonized Tripartite Guideline, International Conference on Harmonization on Technical Requirements for Registration of Pharmaceuticals for Human Use, Q2A, Text on Validation of Analytical Procedures, Step 4 of the ICH process (1994) and Q2B, Validation of Analytical Procedures: Methodology, Step 4 of the ICH process (1996) ICH Steering CommitteeGoogle Scholar
  20. 20.
    Alpert AJ (1990) J Chromatogr 499:177–196CrossRefGoogle Scholar
  21. 21.
    Naidong W (2003) J Chromatogr B 796:209–224CrossRefGoogle Scholar
  22. 22.
    Neue UD, Grumbach ES, Mazzeo JR, Tran K, Wagrowski-Diehl DM (2003) In: Wilson ID (ed) Bioanalytical separations, handbook of analytical separations, Elsevier Science B. V., New York, pp 185–214Google Scholar
  23. 23.
    Neue UD, Pheobe CH, Tran K, Cheng YF, Lu Z (2001) J Chromatogr A 925:49–67CrossRefGoogle Scholar
  24. 24.
    Ali MS, Ghori M, Rafiuddin S, Khatri AR (2007) J Pharm Biomed Anal 43:158–167CrossRefGoogle Scholar
  25. 25.
    Van de Merbel NC, Wilkens G, Fowles S, Oosterhuis B, Jonkman JHG (1998) Chromatographia 47:542–546CrossRefGoogle Scholar
  26. 26.
    Hirt RC, Schmitt RG (1958) Spectrochim Acta 12:127–138CrossRefGoogle Scholar

Copyright information

© Friedr. Vieweg & Sohn Verlag/GWV Fachverlage GmbH 2008

Authors and Affiliations

  • Mohammed Shahid Ali
    • 1
  • Syed Rafiuddin
    • 1
  • Mohsin Ghori
    • 1
  • Aamer Roshanali Khatri
    • 1
  1. 1.Jamjoom Pharmaceuticals Company LimitedJeddahKingdom of Saudi Arabia

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