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Abstrakty
A simple, precise, and accurate stability-indicating high-performance thinlayer chromatographic method for analysis of torsemide in the presence of its degradation products has been established and validated. Optimum separation among torsemide and its degradation products was achieved by use of silica gel 60F254 as stationary phase with ethyl acetate-acetonitrile-water 6.5:3.0:0.5 (v/v) as mobile phase. Densitometric quantification was performed at 297 nm. The retention factors, RF, were 0.59 ± 0.02 for the parent drug, 0.74 ± 0.02 for the degradation product from oxidation, and 0.78 ± 0.02 and 0.96 ± 0.02 for two products of acid degradation. The method was found to be linear in the range 200–800 ng per band both by area and height. The results from analysis of commercial formulations were found to be 98.49 ± 0.32 and 101.75 ± 1.54%. The method was validated for precision, accuracy, specificity, robustness, and ruggedness.
Słowa kluczowe
Czasopismo
Rocznik
Tom
Strony
145--155
Opis fizyczny
Bibliogr. 20 poz., rys., tab.
Twórcy
autor
- Rashtrasant Tukadoji Maharaj Nagpur University Department of Pharmaceutical Sciences Amravati Road Nagpur 440033 Maharashtra India
autor
- Rashtrasant Tukadoji Maharaj Nagpur University Department of Pharmaceutical Sciences Amravati Road Nagpur 440033 Maharashtra India
autor
- Rashtrasant Tukadoji Maharaj Nagpur University Department of Pharmaceutical Sciences Amravati Road Nagpur 440033 Maharashtra India
autor
- Rashtrasant Tukadoji Maharaj Nagpur University Department of Pharmaceutical Sciences Amravati Road Nagpur 440033 Maharashtra India
Bibliografia
- [1] S. Budavari, Merck Index, 12th edn, Merck Research Laboratories, Whitehouse Station, NJ, 1996, pp. 1630
- [2] United States Pharmacopoeia, 30th edn, United States Pharmacopoeial Convention Inc., Rockville, MD, 2007, pp. 3385
- [3] M.B. Barroso, H.D. Meiring, A. de Jong, R.M. Alonso, and R.M. Jimenez, J. Chromatogr. B, 690, 105 (1997)
- [4] K.H. Liu, Y.K. Lee, J.Y. Ryu, D.J. Lee, W. Kang, S.S. Lee, Y.R. Yoon, and J.G. Shin, Chromatographia, 60, 639 (2004)
- [5] I.J. Khan, P. Loya, and M.N. Saraf, Ind. J. Pharm. Edu. Res., 70, 519 (2008)
- [6] S. Engelhardt, I. Meineke, and J. Brockmoller, J. Chromatogr. B, 831, 31 (2006)
- [7] E. Besenfelder, J. Pharm. Biomed. Anal., 5, 259 (1987)
- [8] B.M. Begona, R.M Alonso, and R.M. Jimenez, J. Liq. Chromatogr. Relat. Technol., 19, 179 (1996)
- [9] M.B. Barroso, R.M. Alonso, and R.M. Jimenez, J. Chromatogr. Sci., 39, 491 (2001)
- [10] C. March, D. Farthing, B. Wells, E. Besenfelder, and H.T. Karnes, J. Pharm. Sci., 79, 453 (2006)
- [11] H.T. Karnes, D. Farthing, and E. Besenfelder, J. Liq. Chromatogr., 12, 1809 (1989)
- [12] U. Akesolo, L. Gonzalez, R.M. Jimenez, and R.M. Alonso, J. Chromatogr. A, 990, 271 (2003)
- [13] U. Akesolo, L. Gonzalez, R.M. Jimenez, and R.M. Alonso, Electrophoresis, 23, 230 (2002)
- [14] M.V. Krishna and D.G. Shankar, e-J. Chem., 5, 473 (2008)
- [15] R.B. Kakde, N.K. Chaudhary, A.G. Barsagade, and D.L. Kale, J. GMP Industrial Pharmacy, 3, 27 (2009)
- [16] M.B. Barroso, R.M. Alonso, and R.M. Jimenez, Analyst, 119, 2359 (1994)
- [17] J.M. Rollinger, C.S. Novak, Z.S. Ehen, K. Marthi, J. Therm. Anal. Calor., 73, 519 (2003)
- [18] M. Fernandez, R.M. Alonso, R.M. Jimenez, and M.J. Legorburu, Analyst, 119, 319 (1994)
- [19] ICH Stability Testing of New Drug Substances and Products A(R2), International Conference on Harmonization, IFPMA, Geneva, 2003
- [20] ICH Harmonized Tripartite Guidelines on Validation of Analytical Procedures: Text and Methodology Q2 (R1), Current step 4 version, USA, 2005
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-7418d973-fd43-4615-b583-d444969d0ed3