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The ICH guidance in practice: Stress degradation studies on irbesartan and development of a validated stability-indicating UPLC assay

Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
In this research work comprehensive stress testing of irbesartan was carried out according to ICH guideline Q1A (R2), and a stability-indicating reversed-phase ultra-performance liquid chromatographic (UPLC) assay was established. The drug was subjected to acid (0.1 M HCl), neutral, and alkaline (0.1 M NaOH) hydrolytic conditions at 80°C, and to oxidative decomposition at room temperature. Photolysis was carried out by exposing the drug to sunlight (60,000–70,000 lux) for two days. The solid drug was also subjected to 50°C for 60 days in a hot-air oven. Degradation of the drug was found to occur under alkaline, acidic, and neutral hydrolytic conditions. Separation of the drug and the degradation products was successfully achieved on a BEH (bridged ethylene hybrid) C 18 column with 40:60 aqueous glacial acetic acid (0.2%)-acetonitrile as mobile phase. The flow rate and detection wavelength were 0.1 mL min -1 and 229 nm, respectively. The method was validated and response was found to be linear in the drug concentration range 10–50 μg mL -1 The mean values (±RSD, %) of slope, intercept, and correlation coefficient were 32102 (± 0.0535), 1295 (± 3.02), and 0.9998 (± 0.0493), respectively. RSD in intra-day and inter-day precision studies was <1%. Recovery of the drug from a mixture of degradation products was between 99.26 and 100.01%. The method was specific to the drug, selective to degradation products, and robust. PDA purity test also confirmed the specificity of the method.
Rocznik
Strony
189--205
Opis fizyczny
Bibliogr. 30 poz., rys., tab.
Twórcy
autor
  • Rajiv Gandhi Proudyogiki Vishwavidyalaya School of Pharmaceutical Sciences Bhopal 462036 India prof_piyushtrivedi@yahoo.com
autor
  • Rajiv Gandhi Proudyogiki Vishwavidyalaya School of Pharmaceutical Sciences Bhopal 462036 India prof_piyushtrivedi@yahoo.com
  • Rajiv Gandhi Proudyogiki Vishwavidyalaya School of Pharmaceutical Sciences Bhopal 462036 India prof_piyushtrivedi@yahoo.com
autor
  • Rajiv Gandhi Proudyogiki Vishwavidyalaya School of Pharmaceutical Sciences Bhopal 462036 India prof_piyushtrivedi@yahoo.com
Bibliografia
  • [1] ICH, Stability Testing of New Drug Substances and Products, International Conference on Harmonization, IFPMA, Geneva, 1993
  • [2] ICH, Stability Testing: Photostability Testing New Drug Substances and Products, International Conference on Harmonization, IFPMA, Geneva, 1996
  • [3] ICH, Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization, IFPMA, Geneva, 2003
  • [4] ICH, Specifications: test procedures and acceptance criteria for new drug substances and new drug products, International Conference on Harmonization, IFPMA, Geneva, 1999
  • [5] W. Dong, Modern HPLC for Practicing Scientists, Wiley-Interscience Inc, New Jersey, 2006; pp. 222–239, 232–234.
  • [6] http://pubs.acs.org/subscribe/journals/tcaw/10/i09/html/09dong.html (accessed on 12.07.09)
  • [7] S. Singh and M. Bakshi, Pharm. Tech. On-line, 24, 1–14 (2000)
  • [8] USP/NF, The Official Compendia of Standards, Monograph Development Cardiovascular, 32 (4), 1084, 2400 (2007)
  • [9] The Merck Index, An Encyclopedia of Chemicals, Drugs and Biologicals, 13 , Merck & Co, Inc, New Jersey, USA, pp. 914 (1999)
  • [10] http://www.rxlist.com/avapro-drug.htm (accessed on 12.07.09)
  • [11] http://en.wikipedia.org/wiki/irbesartan (accessed on 12.07.09)
  • [12] http://www.drugbank.ca/drugs/DB01029 (accessed on 13.07.09)
  • [13] G. Lunn and N.R. Schmuff, HPLC Methods for Pharmaceutical Analysis, John Wiley & Sons, Inc., New York, 1997, p. 741
  • [14] D.T.T. Nguyen, D. Guillarme, and S. Rudaz, J. Sep. Sci., 29 , 1836–1848 (2006)
  • [15] J.R. Mazzeo, U.D. Neue, M. Kele, and R.S. Plumb, Anal. Chem., 77 , 460A–467A (2005)
  • [16] A. De Villiers, F. Lestremau, R. Szucs, S. Gelebart, and F. David, J. Chromatogr. A, 1127 , 6069 (2006)
  • [17] S.A.C. Wren and P. Tchelitcheff, J. Chromatogr. A, 1119 , 140–146 (2006)
  • [18] R. Russo, G. Davy, T.T.N. Dao, C. Bicchi, S. Rudaz, and J.-L. Veuthey, J. Chrom. Sci., 46 , 199–208 (2008)
  • [19] S.-Y. Chang and D.B. Whigan, J. Chromatogr. B, 702 , 149–155 (1997)
  • [20] R.M. Alonso, Chromatographia, 52 , 735–740 (2000)
  • [21] H.R. Lusk and E.L. Binder, MDS Pharma Services (2002)
  • [22] N. Erk, J. Chromatogr. B, 784 , 195–201 (2003)
  • [23] F.A. Yazbi and H.H. Hammud, Int. J. Applied Chem., 3 , 973–1092 (2007)
  • [24] http://www.ich.org (ICH website)
  • [25] S. Yoshioka and V.J. Stella, Chemical Stability of Drug Substances, Springer, New Delhi, 2006, pp. 4–28
  • [26] V. Kabra, V. Agrahari, C. Karthikeyan, and P. Trivedi, Tropical J. Pharm. Res., 8 , 79–86 (2009)
  • [27] S. Singh,, B. Singh, R. Bahuguna, L. Wadhwa, and R. Saxena, J. Pharm. Biomed. Anal., 41 , 1037–1047 (2006)
  • [28] S. Singh and M.J. Bakshi, J. Pharm. Biomed. Anal., 28 , 1011–1040 (2002)
  • [29] S. Bhardwaj and S. Singh, J. Pharm. Biomed. Anal., 46 , 113–120 (2008)
  • [30] M. Bakshi, B. Singh, A. Singh, and S. Singh, J. Pharm. Biomed. Anal. 26 , 891–897 (2001)
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-6034e208-7bc0-4a9b-9a42-15a4ff8b9d02
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