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Simultaneous Quantification of Famotidine and Ibuprofen in Pharmaceutical Dosage by Using Validated Stability Indicating LC Method

Author Affiliations

  • 1 Department of Chemistry, Deogiri Science College, Aurangabad 431005, MS, INDIA

Res. J. of Pharmaceutical Sci., Volume 2, Issue (4), Pages 1-9, May,30 (2013)


A reverse phase liquid chromatographic analytical method was developed for the simultaneous determination of Famotidine and Ibuprofen content in tablet dosage form. The chromatographic separation was achieved by using YMC Cyano column with mobile phase containing a gradient mixture of 0.05M ammonium acetate in water as mobile phase A and acetonitrile as mobile phase B at a flow rate of 1.0 ml/min. Both of the analyte were quantified with a UV detector at 270 nm. Famotidine and ibuprofen tablet were subjected to the stress conditions of oxidation, acid hydrolysis, base hydrolysis and thermolysis and photolysis. The tablet was found to be stable under thermal and photolytic conditions but degradation was observed in base hydrolysis, acid hydrolysis and oxidation. The stability-indicating capability of this method was demonstrated by adequate separation of the degradation peaks from those of the actives in the stress degraded samples. The method was validated for linearity, specificity, system suitability, precision and accuracy in accordance with ICH guidelines. The proposed method was applied to quantify famotidine and ibuprofen in the combined pharmaceutical tablet and stability studies of the same.


  1. The Merck Index, 14th edition, Merck Research Laboratories, Division of Merck & Co., Inc., Whitehouse Station (2006)
  2. Humphries T.J. and Merritt G.J., Review article: drug interactions with agents used to treat acid related diseases, Aliment. Pharmacol. Ther., 13, 18-26 (1999)
  3. Yasufumi H., Isao Y., Yoshi I. and Shinichi T., Guanidinothiazole compounds, process for preparation and gastric inhibiting compositions containing them, US Patent No. 4283408, (1981)
  4. Smith J.L., Clinical pharmacology of Famotidine, Digestion, 32, 15-23 (1985)
  5. Reynolds J.C., Famotidine therapy for active duodenal ulcers, A multivariate analysis of factors affecting early healing, Annals of Internal Medicine, 111, 7-14 (1989)
  6. Taha A.S., Laine L.A. and Grahn A., Reducing the incidence of peptic ulcers with Ibuprofen-Famotidine combined pill, HZT-501 (reduce): phase-III, double-blind multi-centre trials, Gut, 60, A8-A9 (2011)
  7. Zey E.G., Shockley T.H., Ryan D.A. and Moss G.L., Method of producing Ibuprofen, US Patent No. US4981995, (1991)
  8. Esch A.Van, Steensel-Moll, Steyerberg E.W., Offringa M., Habbema J.D. and Derksen-Lubsen G., Antipyretic efficacy of Ibuprofen and acetaminophen in children with febrile seizures, Arch Pediatr Adolesc Med, 149, 632-637 (1995)
  9. Su P.H., Chen J.Y., Su C.M., Huang T.C. and Lee H. S., Comparison of Ibuprofen and Indomethacin therapy for patent ductus arteriosus in preterm infants, Pediatrics international, 45, 665–670 (2003)
  10. Helali N., Darghouth F. and Monser L., RP-HPLC: Determination of Famotidine and its potential impurities in pharmaceuticals, Chromatographia, 60, 455-460 (2000)
  11. Helali N. and Monser L., Stability indicating method for Famotidine in pharmaceuticals using porous graphitic carbon column, Journal of Separation Science, 31, 276-282 (2008)
  12. Clakir B., Tosun A.U. and Sahin M. F., Quantitative HPLC analysis of Famotidine in pharmaceutical dosage forms, Pharmacy and Pharmacology Communications, 3, 493-495 (1997)
  13. Suleiman M.S., Muti H.Y., Abdel-Hamid M.E., Hassan M., El-Sayed Y.M. and Najib N.M., A stability indicating HPLC analysis of Famotidine and its application to kinetic studies, Analytical Letters, 22, 1499-1512 (1989)
  14. Zarghi A., Shafaati A., Foroutan S.M. and Khoddam A., Development of a rapid HPLC method for determination of Famotidine in human plasma using a monolithic column, J. Pharm Biomel Anal., 39, 677-680 (2005)
  15. Zhong L. and Yeh K.C., Determination of Famotidine in human plasma by HPLC with column switching, J. Pharm Biomel Anal., 16, 1051-1057 (1998)
  16. Mitic S. S., Miletic G.Z., Pavlovic A. N., Arsic B. B. and Zivanovic V. V., Quantitative analysis of Ibuprofen in pharmaceuticals and human control serum using kinetic spectrophotometry, J. Serb. Chem. Soc., 73, 879-890 (2008)
  17. Chen H., Huang D., Chen Q., Li H., Rapid determination of active constituents in compound Ibuprofen tablets by capillary zone electrophoresis, Chin J Chrom, 16, 289-292 (1998)
  18. Haikala V.E., Heimonen I.K. and Vuorela H.J., Determination of Ibuprofen in ointments by reversed phase liquid chromatography, Journal of Pharmaceutical Sciences, 80, 456-458, (1991)
  19. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline-Validation of Analytical Procedures: Text and Methodology Q2(R1), Current Step 4 version, London, (2005)
  20. Alsante K.M., Ando A., Brown R., Ensing J., Hatajik T.D., Kong W. and Tsuda Y., The role of degradant profiling in active pharmaceutical ingredients and drug products, Adv. Drug Deliv. Rev., 59, 29-37, (2007)
  21. Ruan J., Tattersall P., Lozano R. and Shah P., The role of forced degradation studies in stability indicating HPLC method development, Am. Pharmaceut. Rev., 9, 46-53, (2009)