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In the present study, the degradation behavior of Fenofibrate under different International Conference on Harmonization (ICH) suggested conditions was studied. Characterization of degradation products by liquid chromatography–tandem mass spectrometry (LC–MS/MS) studies in solution form was done, and the possible mechanism for the formation of degradants is discussed. Fenofibrate was subjected to different hydrolytic stress conditions and thermal stress condition (in solid form). Successful separation of drug from degradants was achieved on a C18 column using water–acetonitrile (25:75 v/v) as the mobile phase. Other high-performance liquid chromatography (HPLC) parameters were: flow rate, 1 mL min−1; detection wavelength, 286 nm; column temperature, 25 °C; and injection volume, 20 μL. The method was validated for linearity, precision, accuracy, robustness, and specificity and was stability-indicating one, based on the specificity studies. The drug degraded under acidic, basic, and oxidative hydrolytic stress while it was relatively stable towards neutral hydrolysis and thermal stress. The stressed samples were subjected to LC–MS/MS analysis. On the basis of spectral data, the structures of four degradation products and one interaction product were suggested. Degradation products were characterized to be isopropyl acetate, 2-[4-(4-chlorobenzoyl)phenoxy]-2-methyl propanoic acid, 4-hydroxy benzoic acid, and benzoic acid. The structure of one interaction product was proposed as methyl 2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoate.
Słowa kluczowe
Czasopismo
Rocznik
Tom
Strony
159--173
Opis fizyczny
Bibliogr. 37 poz., rys., tab.
Twórcy
autor
- Department of Quality Assurance Techniques, Sinhgad College of Pharmacy, Pune, Maharashtra, 411041, India and Jawaharlal Nehru Technological University, Hyderabad, India
autor
- Surya School of Pharmacy, Surya Nagar, GST Road, Vikravandi, Villupuram, Tamil Nadu, 605652, India
autor
- Center for Advanced Research in Pharmaceutical Sciences, Poona College of Pharmacy, Bharati Vidyapeeth University, Pune, Maharashtra, 411038, India
Bibliografia
- [1] ICH, Q1A(R2), Stability Testing of New Drug Substances and Products, International Conference on Harmonization, IFPMA, Geneva, February, 2003
- [2] ICH, Q3A(R2), Impurities in New Drug Substances, International Conference on Harmonization, Draft, IFPMA, Geneva, October, 2006
- [3] ICH, Q3B(R2), Impurities in New Drug Products, International Conference on Harmonization, Draft, IFPMA, Geneva, June, 2006
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- [5] D.K. Jain, P. Patel, S. Rajawat, and H.S. Chandel, Int. J. Pure Appl. Chem., 7(2), 139–2012 (2012)
- [6] European Pharmacopoeia, The Director for the Quality of Medicine of the Council of Europe, Strasbourg cedex, France, 2004, pp. 1581–1583
- [7] British Pharmacopoeia, The Medicine and Healthcare Products Regulatory Agency, British Pharma Commission Office, London, 2007, pp. 854–855
- [8] F.M.M. Salamaa, M.W.I. Nassarl, M.M.K. Sharaf, and A.M. Attia, Am. J. Anal. Chem., 2(3), 332–2011 (2011)
- [9] S.D. Kumara, M. Gupta, and R.P. Rao, Int. J. Biol. Pharm. Res., 1(2), 131–2010 (2010)
- [10] P.N. Dhabale and D.S. Gharge, Int. J. ChemTech Res., 2(1), 325–328 (2010)
- [11] R.R. Sevda, A.S. Ravetkar, and P.J. Shirote, Int. J. ChemTech Res., 3(2), 629–2011 (2011)
- [12] S. Sharma and P. Bhandari, J. Pharm. Res., 5, 2311–2314 (2012)
- [13] A. Karunakaran, V. Subhash, R. Chinthala, and J. Muthuvijayan, Stamford J. Pharm. Sci., 4, 58–63 (2011)
- [14] D. Nagavalli, S. Vijayashanthi, S. Jagan, and R. Lakshmisundram, Int. Res. J. Pharm., 2, 146–149 (2011)
- [15] B.G. Choudhari, J. Pharm. Sci. Innovation, 1, 44–48 (2012)
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- [20] G.V. Suresh Kumar and Y. Rajendraprasad, Int. J. PharmTech Res., 2, 2016–2021 (2010)
- [21] P.C. Bhamare, S.B. Bari, S. Natarajan, A.A. Patil, S.H. Patil, and P.T. Shirole, Int. J. PharmTech Res., 3, 505–515 (2011)
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- [24] A. Karunakaran, V. Subhash, R. Chinthala, and J. Muthuvijayan, Stamford J. Pharm. Sci., 4, 58–63 (2011)
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- [37] ICH, Q2 (R1), Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization, Geneva, November, 2005
Uwagi
PL
Opracowanie ze środków MNiSW w ramach umowy 812/P-DUN/2016 na działalność upowszechniającą naukę.
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-e89392e7-d4e7-47b0-a444-e0ea881d5c75