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Development, validation, and pharmacokinetic application of liquid chromatographic method for estimation of raloxifene hydrochloride in rabbit plasma

Autorzy
Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
A rapid and sensitive reverse-phase liquid chromatographic method using ultraviolet detector was developed and validated for estimation of raloxifene hydrochloride in rabbit plasma. Plasma samples were extracted using simple protein precipitation-extraction method. The method was developed under isocratic conditions using a Zorbax SB-C8 analytical column with optimum mobile phase composition of 20 mM pH-4.5 ammonium acetate buffer-acetonitrile (63:37 υ/υ) at a flow rate of 1 mL min-1. The detector response was found to be linear in the concentration range of 50–1500 ng mL-1. High recoveries ranging from 97.2% to 100.2% were obtained, which precludes the use of internal standard. The developed method was found to be accurate, precise, and selective in the estimation of raloxifene hydrochloride in rabbit plasma based on the results of method validation carried out as per standard guidelines. The drug was found to be stable under various processing and storage conditions. The developed method was successfully applied in the estimation of raloxifene hydrochloride and the determination of various pharmacokinetic parameters post-intravenous bolus administration of drug in rabbits.
Rocznik
Strony
559--573
Opis fizyczny
Bibliogr. 24 poz., rys., tab.
Twórcy
autor
  • BITS-Pilani Hyderabad Campus Pharmacy Department Ranga Reddy (Dist.) Jawaharnagar Andhra Pradesh India
autor
  • BITS-Pilani Hyderabad Campus Pharmacy Department Ranga Reddy (Dist.) Jawaharnagar Andhra Pradesh India
autor
  • BITS-Pilani Hyderabad Campus Pharmacy Department Ranga Reddy (Dist.) Jawaharnagar Andhra Pradesh India
Bibliografia
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  • [2] J.A. Scott, C.C. Da Camara, and J.E. Early, Am. Fam. Physician, 60, 1131 (1999)
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  • [4] K.R. Snyder, N. Sparano, and J.M. Malinowski, Am. J. Health-Syst. Pharm., 57, 1669 (2000)
  • [5] D. Hochner-Celnikier, Eur. J. Obstet. Gynecol. Reprod. Biol., 85, 23 (1999)
  • [6] J. Trontelj, T. Vovk, M. Bogataj, and A. Mrhar, Pharmacol. Res., 52, 334 (2005)
  • [7] D.C. Pavithra and L. Sivasubramanian, Indian J. Pharm. Sci., 68, 401 (2006)
  • [8] B. Kanakapura, A.K. Urdigere, and K. Tharpa, Acta. Pharm., 58, 347 (2008)
  • [9] A.M. Mathrusri, M.E. Bhanoji Rao and B.V. Ravikumar, E-J. Chem., 4, 79 (2007)
  • [10] B. Kanakapura, A.K. Urdigere, K. Tharpa, and K.B. Vinay, J. Chil. Chem. Soc., 53, 1635 (2008)
  • [11] B. Kanakapura, K. Tharpa, A.K. Urdigere, N. Rajendraprasad, S.G. Hiriyanna, and K.B. Vinay, Arch. Pharm. Res., 32, 1271 (2009)
  • [12] T. Pérez-Ruiz, C. Martínez-Lozano, A. Sanz, and E. Bravo, J. Pharm. Biomed. Anal., 34, 891 (2004)
  • [13] C.Z. Huang and Y.F. Li, Anal. Chim. Acta., 500, 105 (2003)
  • [14] Z.Y. Yang, Z.F. Zhang, X.B. He, G.Y. Zhao, and Y.Q. Zhang, Chromatographia, 65, 197 (2007)
  • [15] A.K. Urdigere, K. Basavaiah, K. Tharpa, and K.B. Vinay, Chem. Ind. Chem. Eng. Q., 15, 119 (2009)
  • [16] M.F. Wempe, V.J. Wacher, K.M. Ruble, M.G. Ramsey, K.J. Edgar, N.L. Buchanan, and C.M. Buchanan, Int. J. Pharm., 346, 25 (2008)
  • [17] D. Bikiaris, V. Karavelidis, and E. Karavas, Molecules, 14, 2410 (2009)
  • [18] S. Castañeda, E. Calvo, R. Largo, R. González-González, C. Piedra, M. Díaz-Curiel, and G. Herrero-Beaumont, J. Bone Miner. Metab., 26, 53 (2008)
  • [19] K. Kaveh, R. Ibrahim, M.Z. AbuBakar, and T.A. Ibrahim, Am. J. Anim. Vet. Sci., 5, 139 (2010)
  • [20] A.S. Turner, Eur. Cells Mat., 1, 66 (2001)
  • [21] R.T. Turner, A. Maran, S. Lotinun, T. Hefferan, G.L. Evans, M. Zhang, and J.D. Sibonga, Rev. Endocr. Metab. Disord., 2, 117 (2001)
  • [22] Guidelines for Pre-Clinical Evaluation and Clinical Trials in Osteoporosis. World Health Organization, Geneva, 1998
  • [23] International Conference on Harmonization (ICH), Harmonized Tripartite Guideline on, Topic Q2B, Notes for Guidelines for Validation of Analytical Procedures: Methodology, The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit, 1996
  • [24] Guidance for Industry: Bioanalytical Method Validation, U.S. Department of Health and Human Services, Food and Drug Administration, 2001
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-7eb31fdc-71c0-40f4-ab86-be9ab15a11ce
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