Abstract
A quantitative densitometric thin-layer chromatographic method for determination of nefopam hydrochloride in pharmaceutical preparations has been established and validated. Nefopam from the formulations was separated and identified on silica gel 60 F254 TLC plates with chloroform-methanol-glacial acetic acid (9: 2: 0.1, v/v/v) as mobile phase. Densitometric quantification was performed at absorbance maximum 266 nm. The method was validated for linearity, sensitivity, precision and recovery in accordance with ICH guidelines. The presented method is selective and specific with potential application in pharmaceutical analysis. Nefopam hydrochloride was subjected to acidic and alkaline hydrolysis at different temperatures. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating one.
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References
The Extra Pharmacopoeia, Reynolds, J.E.F., Ed., London: Martindale Pharmaceutical Press, 1993, 30th ed.
Shama, S.A. and Amin, A.S., Spectrochim. Acta, Part A, 2004, vol. 60, p. 1769.
Chang, S.F., Hansen, C.S., Fox, J.M., and Ober, R.E., J. Chromatogr., 1981, vol. 13, p. 79.
Schuppan, D., Hansen, C.S., and Ober, R.E., J. Pharm. Sci., 1978, 2006, vol. 67, p. 1720.
Bondesson, U. and Johansson, I.M.J., J. Chromatogr. B, 1986, vol. 377, p. 379.
Ehrsson, H. and Eksborg, S.J., J. Chromatogr. A, 1977, vol. 136, p. 147.
Aymard, G., Warot, D., Demolis, P., Laville, I., and Diquet, B., J. Pharm. Biomed. Anal., 2002, vol. 30, p. 1013.
Hoizey, G., Goglin, A., Malinovsky, J.M., Robinet, A., Binet, L., Kaltenbach, M.L., Millart, H., and Lamiable, D., J. Pharm. Biomed. Anal., 2006, vol. 42, p. 593.
Chang, L.C. and Wang, D.P., J. Liq. Chromatogr. Relat. Technol., 1994, vol. 17, p. 1971.
Burton, L.C., Loftus, N.J., Vere, D.W., and Whelpton, R., J. Chromatogr., 1990, vol. 526, p. 159.
Tu, Y.H., Wang, D.P., and Allen, L.V., Jr., J. Pharm. Sci., 1990, vol. 79, p. 48.
ICH Guideline Q2B on “Validation of Analytical Procedures: Text and Methodology”, International Conference on Harmonization, November 6, 2006, incorp. November 2005, Genewa.
Pawełczyk, E. and Hermann, T. Podstawy trwałoći leków, Warszawa: PZWL, 1982.
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Starek, M., Dąbrowska, M. Development and validation of a TLC-densitometry method for quantitative analysis of nefopam hydrochloride beside its degradation products. J Anal Chem 67, 733–739 (2012). https://doi.org/10.1134/S1061934812080072
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DOI: https://doi.org/10.1134/S1061934812080072