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A Validated Stability Indicating RP-HPLC Method for Nabumetone, Identification and Characterization of Forced Degradation Products of Nabumetone Using LC-MS/MS
Corresponding Author(s) : Sanjay Sawant
Asian Journal of Chemistry,
Vol. 25 No. 11 (2013): Vol 25 Issue 11
Abstract
The objective of the present study was to report the stability of novel non-steroidal antiinflammatory drug (NSAID), nabumetone based on the information obtained from forced degradation studies. Nabumetone was subjected to forced hydrolytic, oxidative, photolytic and thermal stress in accordance with the ICH guideline Q1A (R2). The drug showed labiality under only photo-neutral condition by forming a single degradation product. HPLC separation of the drug and the degradation product was achieved on a hypersil gold C18 column (4.6 mm × 250 mm, 5 μm) using an isocratic elution method. The method was extended to LC-MS/MS for characterization of the degradation product and the pathway of decomposition was proposed. Validation of the LC-DAD method was carried out in accordance with ICH guidelines. The method met all required criteria and was applied for analysis of commercially available tablets.
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- ICH, Q1A (R2)-Stability Testing of New Drug Substances and Products, International Conference on Harmonization, IFPMA, Geneva (2003).
- WHO-Draft Stability Testing of Active Pharmaceutical Ingredients and Pharmaceutical Products, World Health Organization, Geneva (2007).
- CPMP-Note for Guidance on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products, Committee for Proprietary Medicinal Products, EMEA, London (2002).
- TPD-Guidance for Industry Stability Testing of Existing Drug Substances and Products, Therapeutic Products Directorate, Health Canada, Ottawa, ON (2003).
- M. Bakshi and S. Singh, J. Pharm. Biomed. Anal., 28, 1011 (2002).
- Y. Wu, Biomed. Chromatogr., 14, 384 (2000).
- N.M. Davies, Clin. Pharmacokinet., 33, 403 (1997).
- O.R. Carryl and R.S. Spangler, Scand. J. Rheumatol., 24, 336 (1995).
- G.B.F. Porro, M. Montrone, P.I. Caruso and V. Imbesi,Am. J. Gastroenterol., 90, 1485 (1995).
- W. Bensen and A. Zizzo, Can. Family Physician, 44, 101 (1998).
- M. Valero and S.M. Costa, J. Photochem. Photobiol. A, 157, 93 (2003).
- M. Valero, J. Photochem. Photobiol. A, 163, 159 (2004).
- N. Sethi,A. Anand, K.K. Chandrul, G. Jain and K.S. Srinivas, J. Chromatogr. Sci., 50, 85 (2012).
- S. Singh and M. Bakshi, Pharm. Technol., pp. 1-14 (2000).
- ICH, Q2 (R1)-Validation of Analytical Procedures- Text and Methodology, International Conference on Harmonization Geneva, Switzerland (2005).
References
ICH, Q1A (R2)-Stability Testing of New Drug Substances and Products, International Conference on Harmonization, IFPMA, Geneva (2003).
WHO-Draft Stability Testing of Active Pharmaceutical Ingredients and Pharmaceutical Products, World Health Organization, Geneva (2007).
CPMP-Note for Guidance on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products, Committee for Proprietary Medicinal Products, EMEA, London (2002).
TPD-Guidance for Industry Stability Testing of Existing Drug Substances and Products, Therapeutic Products Directorate, Health Canada, Ottawa, ON (2003).
M. Bakshi and S. Singh, J. Pharm. Biomed. Anal., 28, 1011 (2002).
Y. Wu, Biomed. Chromatogr., 14, 384 (2000).
N.M. Davies, Clin. Pharmacokinet., 33, 403 (1997).
O.R. Carryl and R.S. Spangler, Scand. J. Rheumatol., 24, 336 (1995).
G.B.F. Porro, M. Montrone, P.I. Caruso and V. Imbesi,Am. J. Gastroenterol., 90, 1485 (1995).
W. Bensen and A. Zizzo, Can. Family Physician, 44, 101 (1998).
M. Valero and S.M. Costa, J. Photochem. Photobiol. A, 157, 93 (2003).
M. Valero, J. Photochem. Photobiol. A, 163, 159 (2004).
N. Sethi,A. Anand, K.K. Chandrul, G. Jain and K.S. Srinivas, J. Chromatogr. Sci., 50, 85 (2012).
S. Singh and M. Bakshi, Pharm. Technol., pp. 1-14 (2000).
ICH, Q2 (R1)-Validation of Analytical Procedures- Text and Methodology, International Conference on Harmonization Geneva, Switzerland (2005).