AJAC  Vol.2 No.5 , September 2011
A Validated Stability Indicating LC Method for Amlexanox in Bulk Drugs
Abstract: A novel and sensitive stability indicating RP-HPLC method has been developed for the quantitative determination of amlexanox in bulk drugs. The separation was accomplished on C18 column using 10 mM ammonium dihydrogen orthophosphate (pH adjusted to 4.8 by using ortho phosphoric acid) and methanol (30:70 v/v) as mobile phase in an isocratic elution mode at a flow rate of 1.0 mL min-1. The eluents were monitored by PDA detector at 245 nm. The drug was subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. Significant degradation was found under basic, acidic stress and UV light. The resolution (Rs) between amlexanox and its degradation products was found to be greater than 2.5. Regression analysis shows correlation coefficient greater than 0.999 for amlexanox. The inter and intraday precision values for amlexanox were found to be within 1.0% RSD. The method has shown good and consistent recoveries for amlexanox in bulk drugs (98.86% - 101.05%). The developed method was validated with respect to linearity, accuracy, precision and robustness.
Cite this paper: nullB. Sundar and M. Nazeerunnisa, "A Validated Stability Indicating LC Method for Amlexanox in Bulk Drugs," American Journal of Analytical Chemistry, Vol. 2 No. 5, 2011, pp. 533-538. doi: 10.4236/ajac.2011.25063.

[1]   J. Bell, “Amlexanox for the Treatment of Recurrent Aphthous Ulcers,” Clinical Drug Investigation, Vol. 25, No. 9, 2005, pp. 555-566. doi:org/10.2165/00044011-200525090-00001

[2]   H. Makino, T. Saijo, Y. Ashida, H. Kuriki and Y. Maki, “Mechanism of Action of an Antiallergic Agent, Am- lexanox (AA-673), in Inhibiting Histamine Release from Mast Cells,” International Archives of Allergy and Immunology, Vol. 82, No. 1, 1987, pp. 66-71. doi:org/10.1159/000234292

[3]   C. Scully and S. Porter, “Oral mucosal disease: Recurrent aphthous stomatitis,” British Journal of Oral and Maxil-lofacial Surgery, Vol. 46, No. 3, 2008, pp. 198-206. doi:org/10.1016/j.bjoms.2007.07.201

[4]   J. Liu, X. Zeng, Q. Chen, Y. Cai, F. Chen , Y. Wang, H. Zhou, M. Lin, J. Shi, Z. Wang and Y. Zhang, “An Evaluation on the Efficacy and Safety of Amlexanox Oral Adhesive Tablets in the Treatment of Recurrent Minor Aphthous Ulceration in a Chinese Cohort: A Randomized, Double-Blind, Vehicle-Controlled, Unparallel Multicenter Clinical Trial,” Oral Surgery Oral Medicine Oral Pa-Thologz Oral Radiology and Endodontology, Vol. 102, No. 4, 2006, pp. 475-481.

[5]   M. Sugiura, R. Hayakawa and T. Osada, “Fixed drug Eruption Due to Amlexanox,” Contact Dermatitis, Vol. 38, No. 2, 1998, pp. 65-67. doi:org/10.1111/j.1600-0536.1998.tb05654.x

[6]   S. McComish, A. Mize, J. Harris, N. Premkumar and L. E. Colon, “A High-Pressure Liquid Chromatographic Method for Measuring Mitotane: [1,1-(o,p-Dichlorodiphenyl)-2,2- Dichloroethane] and Its Metabolite 1,1-(o,p'-Dichlorodi- phenyl)-2,2-dichloroethene in Plasma,” Therapeutic Drug Monitoring, Vol. 17, No. 5, 1995, pp. 526-531. doi:org/10.1097/00007691-199510000-00015

[7]   T Shishibori, “Three Distinct Anti-Allergic Drugs, Am-lexanox, Cromolyn and Tranilast, Bind to S100A12 and S100A13 of the S100 Protein Family,” Biochemical Journal, Vol. 338, 1999, pp. 583-589.

[8]   A. Khandwala, R. G. V. Inwegen and M. C. Alfano, “5% Amlexanox Oral Paste, a New Treatment for Recurrent Minor Aphthous Ulcers: I. Clinical Demonstration of Acceleration of Healing and Resolution of Pain,” Oral Surgery Oral Medicine Oral Pathologz Oral Radiology and Endodontology, Vol. 83, No. 2, 1997, pp. 222- 230.

[9]   A. Khandwala, R. G. V. Inwegen, M. R. Charney and M. C. Alfano, “5% Amlexanox Oral Paste, a New Treatment for Recurrent Minor Aphthous Ulcers II: Pharmacokinetics and Demonstration of Clinical Safety,” Oral Surgery Oral Medicine Oral Pathologz Oral Radiology and Endodon- tology, Vol. 83, No. 2, 1997, pp. 231-238.

[10]   J. Jacob, “Stable Viscous Liquid Formulations of Am-lexanox for the Prevention and Treatment of Mucosal Diseases and Disorders,” US Patent App. 09/971, 2001, p. 562.

[11]   USP, “United States pharmacopoeia,” 32nd Edition, United States Pharmacopeial Convention, Rockville, 2008.

[12]   International Federation of Pharmaceutical Manufactures & Associations, “ICH Stability Testing of New Drug Substances and Products Q1A (R2),” International Con-ference on Harmonization, Geneva, 2003.

[13]   M. Bakshi and S. Singh, “Development of Validated Stability-Indicating Assay Methods-Critical Review,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 28, No. 6, 2002, pp. 1011-1040. doi:org/10.1016/S0731-7085(02)00047-X

[14]   U. S. Food and Drug Administration, “ICH Guidelines on Validation of Analytical Procedures: Text and Metho-dology Q2 (R1),” Federal Register, FDA, Silver Spring 2005.