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Isolation and Characterization of Fesoterodine Fumarate Related Impurity
Corresponding Author(s) : Manohar C. Sonanis
Asian Journal of Chemistry,
Vol. 25 No. 11 (2013): Vol 25 Issue 11
Abstract
During analytical method for the determination of related substances of fesoterodine fumarate using RP-HPLC, one unknown impurity was observed more than 0.1 % level and also keeps on increasing in forced degradation study. Hence it was desirable to isolate, identify and characterize this impurity using advanced analytical techniques. A simple, sensitive and specific RP-HPLC method was developed for the quantification of related impurities of fesoterodine fumarate. The chromatographic separation was accomplished on a YMC Pak ODS-A (150 mm × 4.6 mm), 5 μ column using mobile phase system with gradient elution of solvent-A (0.1 % trifluro acetic acid in water and methanol in the ratio of 70:30 v/v) and solvent-B (acetonitrile). The analytes were detected at 215 nm using photo diode-array (PDA) detector. The investigated impurity has been isolated using preparative RP-HPLC method using YMC Pak ODS-A (250 mm × 50 mm) 12 μ. Then the isolated impurity was identified and characterized.
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- J. Nie, Y. Wen, Q. Yu, B. Xiang and Y. Feng, SePu, 24, 52 (2006).
- K.E. McCarthy, Q. Wang, E.W. Tsai, R.E. Gilbert, D.P. Ip and M.A. Brooks, J. Pharm. Biomed. Anal., 17, 671 (1998).
- R.A. Seburg, J.M. Ballard, T.-L. Hwang and C.M. Sullivan, J. Pharm. Biomed. Anal., 42, 411 (2006).
- D.L. Hertzog, J.F. McCafferty, X. Fang, R.J. Tyrrell and R.A. Reed, J. Pharm. Biomed. Anal., 30, 747 (2002).
- ICH Guideline Q3A(R), Impurities in New Drug Substances, 7 February (2002).
- K.D. Altria, J. Chromatogr. A, 735, 43 (1996).
References
J. Nie, Y. Wen, Q. Yu, B. Xiang and Y. Feng, SePu, 24, 52 (2006).
K.E. McCarthy, Q. Wang, E.W. Tsai, R.E. Gilbert, D.P. Ip and M.A. Brooks, J. Pharm. Biomed. Anal., 17, 671 (1998).
R.A. Seburg, J.M. Ballard, T.-L. Hwang and C.M. Sullivan, J. Pharm. Biomed. Anal., 42, 411 (2006).
D.L. Hertzog, J.F. McCafferty, X. Fang, R.J. Tyrrell and R.A. Reed, J. Pharm. Biomed. Anal., 30, 747 (2002).
ICH Guideline Q3A(R), Impurities in New Drug Substances, 7 February (2002).
K.D. Altria, J. Chromatogr. A, 735, 43 (1996).