Development and validation of a simple stability-indicating high performance liquid chromatographic method for the determination of miconazole nitrate in bulk and cream formulations

DE ZAN, MERCEDES; MS CAMARA,; JC ROBLES,; KERGARAVAT; GOICOECHEA, HÉCTOR C

TALANTA

Elsevier

Lugar: Amsterdam; Año: 2009 vol. 79 p. 762 - 767

0039-9140

A simple and stability-indicating high performance liquid chromatographic method was developed andvalidated for the determination of miconazole nitrate in bulk and cream preparations. The extraction stepfor cream samples consisted in a warming, cooling and centrifugation procedure that assures the eliminationof the lipophilic matrix component, in order to avoid further precipitation in the chromatographicsystem. Separation was achieved on a ZORBAX Eclipse XDB – C18 (4.6mm×150mm, 5m particle size)column, using a mobile phase consisting of water, methanol and acetonitrile, in a flow and solvent gradientelution for 15 min. The column was maintained at 25 ◦C and 10L of solutions were injected. UVdetection was performed at 232 nm, although employment of a diode array detector allowed selectivityconfirmation by peak purity evaluation. The methodwas validated reaching satisfactory results for selectivity,precision and accuracy. Degradation products in naturally aged samples could be simultaneouslyevaluated, without interferences in the quantitative analysis.