Determination of methylparaben, propylparaben, clotrimazole and its degradation products in topical cream by RP-HPLC
- 515 Downloads
Reversed-phase, high-performance liquid chromatographic (RP-HPLC) methods with UV detection were developed and validated for determination of compounds in a topical cream. The first method describes determination of the active component clotrimazole and two preservatives present in the cream; methylparaben and propylparaben. The second method describes determination of two degradation products of clotrimazole, imidazole and (2-chlorophenyl) diphenylmethanol, in a topical cream after long-term stability tests.
Chromatographic separation was on a Purospher RP-18e column; the mobile phase in Method1 for separation of clotrimazole, methylparaben and propylparaben comprises acetonitrile and water (70:30 v/v). For determination of degradations products-imidazole and (2-chlorophenyl) diphenylmethanol—the optimum composition of mobile phase in Method2 was acetonitrile and water (75:25 v/v) apparent pH* 2.7. Analysis time was <10 min for both methods. The methods were found to be applicable for routine analysis of the active compound clotrimazole, preservatives and degradation products in the pharmaceutical product: topical cream 1% Clotrimazol Cream.
Key WordsColumn liquid chromatography Pharmaceuticals Degradation products Methylparaben Propylparaben Clotrimazol
- Valenta, C.; Lecer, A.; Spiegl, P.Pharmazie 1992,47 (8), 641–642.Google Scholar
- Hoogerheide, J.C.; Strusiak, S.H.; Taddei, C.R.; Townley, E.R.; Wyka, B.E.J. Assoc. Off. Anal. Chem. 1981,64 (4), 864–869.Google Scholar
- Zegarelli, D.J.Otolaryngol. Clin. North. Am. 1993,26 (6), 1069–1089.Google Scholar
- United States Pharmacopoeia XXIV, The United States Pharmacopeial Convention, Inc., Rockville, MD,2000.Google Scholar
- Bedair, M.M.; Korany, M.A.; Elsayed, M.H.; Fahmy, O.T.J. Assoc. Off. Anal. Chem. 1989,72 (3), 432–435.Google Scholar
- Indrayanto, G.; Aditama, L.; Tanudjaja, W.; Widjaja, S.J. Planar. Chromatogr. Mod. TLC 1998,11 (3), 201–204.Google Scholar
- del-Fabro, B.; Kacic, N.; Prosek, M.J. Planar. Chromatogr. Mod. TLC 1997,10 (3), 178–181.Google Scholar
- Kollmorgen, D.; Kraut, B.J. Chromatogr. B 1998,707, 181–187.Google Scholar