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Abstrakty
The present study reports the dissolution method for a novel fixed dose combination (FDC) containing etodolac (ET) and propranolol hydrochloride (PH) developed utilizing USP Apparatus 1 (basket) at 100 rpm with 1000 mL of phosphate buffer (pH 6.8; 0.05 M) medium at 37°C. An isocratic reversed-phase liquid chromatographic (RPLC) method was also developed for the simultaneous determination of ET and PH on an octadecylsilica column using phosphate buffer (pH 5.5) and acetonitrile (60:40, υ/υ) as the mobile phase with ultraviolet (UV) detection at 292 nm. Validation data were obtained, which demonstrated that the dissolution methodology is accurate, precise, linear, and rugged for the combination tablets.
Czasopismo
Rocznik
Tom
Strony
551--566
Opis fizyczny
Bibliogr. 20 poz., rys., tab.
Twórcy
autor
- National College Department of Chemistry Trichirapalli Pin code 620001 Tamilnadu India
autor
- Mother Theresa Post Graduate & Research Institute of Health Sciences Department of Chemistry, College of Pharmacy Gorimedu Puducherry Pin code 605006 India
autor
- Takeida Pharmaceuticals Kathirkamam Puducherry Pin code 605009 India
autor
- National College Department of Chemistry Trichirapalli Pin code 620001 Tamilnadu India
Bibliografia
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- [5] Food and Drug Administration: Guidance for Industry. Dissolution Testing of Immediate Release Solid Oral Dosage Forms, US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research, Rockville, MD, 1997
- [6] M. Siewert, J. Dressman, C.K. Brown, and V.P. Shah, AAPS Pharm. Sci. Technol., 4, Article 7 (2003)
- [7] http://www.clinicaltrial.gov/ct2/show/NCT00888797
- [8] US Pharmacopoeia, 32nd edn, NF-27, 2, 2335–2337; 3, 3426–3432 (2009)
- [9] British Pharmacopoeia, 3, 2564–2566 (2007)
- [10] E.C. Gil, A.I. Colarte, B. Bataille, J.L. Pedraz, F. Rodriguez, and J. Heinamaki, Inter. J. Pharmaceutics, 317, 32–39 (2006)
- [11] J. Akbari, A. Nokhodchi, D. Farid, M. Adrangui, M.R. Siahi-Shadbad, and M. Saeedi, Il Farmaco, 59, 155–161 (2004)
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- [15] V.G. Dongre, S.B. Shah, G.S. Bayes, M. Phadke, and V.K. Jadhav, Chromatographia 69, 1019–1023 (2009)
- [16] H.S. Lee, I.M. Kang, H.W. Lee, J.H. Seo, J.H. Ryu, S.J. Choi, M.J. Lee, S.Y. Jeong, Y.W. Cho, and K.T. Lee, J. Chromatogr. B, 863, 158–162 (2008)
- [17] F.F.T. Ververs, H.G. Schaefer, J.F. Lefevre, L.M. Lopez, and H. Derendorf, J. Pharm. Biomed. Anal., 8, 535–539 (1990)
- [18] P. Partani, Y. Modhave, S. Gurule, A. Khuroo, and T. Monif, J. Pharm. Biomed. Anal., 50, 966–976 (2009)
- [19] ICH, Validation of Analytical Procedures: Text and Methodology (Q2R1), International Conference on Harmonization, Geneva (2005)
- [20] US Pharmacopoeia, 32nd edn., NF-27 〈1092〉 the Dissolution Procedure: Development and Validation, US Pharmacopoeial Convention, Rockville, MD (2009)
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-e95602f5-9084-45cd-9655-7f70f2590906