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Journal of Liquid Chromatography & Related Technologies Volume 38, 2015 - Issue 9
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Original Articles

Identification, Synthesis, and Characterization of Unknown Impurity in the Famotidine Powder for Oral Suspension Due to Excipient Interaction by UPLC-MS/MS and NMR

Kishore Kumar HothaNovel Laboratories, Inc., Somerset, New Jersey, USACorrespondence[email protected] [email protected]
,
Tejashkumar PatelNovel Laboratories, Inc., Somerset, New Jersey, USA
,
Swapan RoychowdhuryNovel Laboratories, Inc., Somerset, New Jersey, USA
&
Veerappan SubramanianNovel Laboratories, Inc., Somerset, New Jersey, USA
Pages 977-985 | Published online: 26 Mar 2015

References

  • Langtry, H. D.; Grant, S. M.; Goa, K. L. Famotidine. An Updated Review of Its Pharmacodynamic and Pharmacokinetic Properties, and Therapeutic Use in Peptic Ulcer Disease and Other Allied Diseases. Drugs 1989, 38, 551–590.
  • ICH Guideline Q3A (R). Impurities in New Drug Substances, February 7, 2002.
  • Helali, N.; Darghouth, F.; Monser, L. RP-HPLC Determination of Famotidine and Its Potential Impurities in Pharmaceuticals. Chromatographia 2004, 60, 455–460.
  • Walash, M. I.; El-Brashy, A.; El-Enany, N.; Kamel, M. E. Spectro Fluorimetric Determination of Famotidine in Pharmaceutical Preparations and Biological Fluids. Application to Stability Studies. J. Fluoresc. 2009, 19, 333–344.
  • Helali, N.; Tran, N. T.; Monser, L.; Taverna, M. Capillary Zone Electrophoresis Method for the Determination of Famotidine and Related Impurities in Pharmaceuticals. Talanta 2008, 74, 694–698.
  • Vamsi Krishna, M.; Madhavi, G.; Rama Prasad, L. A.; Gowri Sankar, G. Impurity Profiling of Famotidine in Bulk Drugs and Pharmaceutical Formulations by RP-HPLC Method Using Ion Pairing Agent. Der Pharmacia Lettre 2010, 2 (3), 1–11.
  • Hotha, K. K.; Reddy, S. P. K.; Raju, V. K.; Ravindranath, L. K. Forced Degradation Studies: Practical Approch-Overview of Regulatory Guidance and Literature for the Drug Products and Drug Substances. Int. Res. J. Pharm. 2013, 4 (5), 78–85.
  • ICH Q2 (R1). Validation of Analytical Procedures: Text and Methodology, 2005.
  • ICH Q1A (R2). Stability Testing of New Drug Substances and Products, 2000.
  • Benzaldehyde: Bureau of Environmental Health; Health Assessment Section. http://www.odh.ohio.gov/~/media/ODH/ASSETS/Files/eh/HAS/Benzaldehyde.ashx ( accessed Feb 13, 2015).

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