, Volume 69, Issue 9–10, pp 1013–1018 | Cite as

Development and Validation of a Stability Indicating LC Method for the Determination of Faropenem in Pharmaceutical Formulations

  • Shobhana K. Menon
  • Jayesh G. Panchal
  • Ravindra V. Patel
Full Short Communication


A simple, selective and sensitive stability indicating LC method has been developed and validated for the determination of faropenem in bulk drug and pharmaceutical formulations in the presence of degradation products. The separation was achieved by using an isocratic mobile phase mixture of acetate buffer of pH 3.5 and methanol (65:35, v/v) and 250 mm × 4.6 mm I.D., 5 μm particle size SGE make Wakosil C-18 AR column at flow rate of 1.0 mL min−1 with detection at 305 nm. The retention time of faropenem is 6.63 min and was linear in the range of 5–75 μg mL−1 (r = 0.9999). The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation and was found to be unstable in all the stress conditions. The proposed method was successfully employed for quantification of faropenem in bulk drug and its pharmaceutical formulations.


Column liquid chromatography Stability indicating method Pharmaceutical preparation Faropenem 



Financial assistance from UGC, New Delhi is gratefully acknowledged.


  1. 1.
    Woodcock J, Andrews J, Brenwald N, Ashby J, Wise R (1997) J Antimicrob Chemother 39:35–43. doi: 10.1093/jac/39.1.35 CrossRefGoogle Scholar
  2. 2.
    Boswell F, Andrews J, Wise R (1997) J Antimicrob Chemother 39:415–418. doi: 10.1093/jac/39.3.415 CrossRefGoogle Scholar
  3. 3.
    Marchese A, Debbia E, Bryskier A, Schito G (1999) Clin Microbiol Infect 5:282–287. doi: 10.1111/j.1469-0691.1999.tb00142.x CrossRefGoogle Scholar
  4. 4.
    Cormian M, Jones R (1995) J Antimicrob Chemother 35:535–539. doi: 10.1093/jac/35.4.535 CrossRefGoogle Scholar
  5. 5.
    Dana M, Franz S, Jan V, Ad CF (2002) J Antimicrob Chemother 50:293–307. doi: 10.1093/jac/dkf098 CrossRefGoogle Scholar
  6. 6.
    Gao S, Chen W, Tao X, Miao H, Yang S, Wu R (2008) Biomed Chromatogr 22(1):5–12. doi: 10.1002/bmc.886 CrossRefGoogle Scholar
  7. 7.
    Nirogi R, Kandikere V, Shrivastava W, Mudigonda K (2005) Arzneim- Forsch 55(12):762–766Google Scholar
  8. 8.
    Sun YX, Zhao LM, Qiu F, He XJ (2007) Chin J N Drugs And Clin Remedies 26(10):762–764Google Scholar
  9. 9.
    Xie J, Zhou Y, Liu Y-w (2006) Chin J Clin Pharmacol 22(3):218–221Google Scholar
  10. 10.
    Hu Y-q, Zhang W-d, Wang Y-c (2006) Chin J Pharm Anal 26(11):1555–1557Google Scholar
  11. 11.
    Yan X-y, Hu X, He X-r (2006) Chin J Pharm Anal 26(7):965–967Google Scholar
  12. 12.
    Zhao X, Hu C-q, Jin S-h (2005) Chin Pharma J 40(5):385–387Google Scholar
  13. 13.
    Xia Z, Chang-qin H, Shao-hong J (2005) Chin J Antibiot 30(6):341–343Google Scholar
  14. 14.
    International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceutical for Human Use (2005) Validation of analytical procedures: text and methodology Q2(R1), November, 2005, pp 1–13Google Scholar
  15. 15.
    International Conference on Harmonisation (ICH) of Technical Requirements for the Registration of Pharmaceutical for Human Use (2003) Stability testing of new drugs substance and products Q1A(R2), February, 2003, pp 1–18Google Scholar
  16. 16.
    USP (2007) United States pharmacopoeia, 30th edn. United States Pharmacopeial Convention, RockvilleGoogle Scholar
  17. 17.
    Singh S, Singh B, Bahuguna R, Wadhwa L, Saxena R (2006) J Pharm Biomed Anal 41:1037–1040. doi: 10.1016/j.jpba.2006.01.030 CrossRefGoogle Scholar
  18. 18.
    Carstensen JT, Rhodes CT (eds) (2000) Drug Stability: Principles and Practices, 3rd edn. Marcel Dekker, Inc., New YorkGoogle Scholar

Copyright information

© Vieweg+Teubner | GWV Fachverlage GmbH 2009

Authors and Affiliations

  • Shobhana K. Menon
    • 1
  • Jayesh G. Panchal
    • 1
  • Ravindra V. Patel
    • 1
  1. 1.Department of ChemistrySchool of Science, Gujarat UniversityAhmedabadIndia

Personalised recommendations