Simultaneous HPLC Determination of Butenafine Hydrochloride and Betamethasone in a Cream Formulation

Glenmark Pharmaceuticals Ltd, R&D Centre, Plot No. C-152, MIDC, Malegaon, Sinnar-422 113, India.
Indian Journal of Pharmaceutical Sciences (Impact Factor: 0.3). 09/2009; 71(5):547-51. DOI: 10.4103/0250-474X.58194
Source: PubMed

ABSTRACT A fast, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of butenafine hydrochloride and betamethasone in cream formulation. The determination was carried out on licrocart licrosphere RP-select B (250x4.6 mm, 5 mu) column in isocratic mode, the mobile phase consisting of 50 mM ammonium acetate buffer and acetonitrile in the ratio of 60:40, adjusted to pH 4.5 +/- 0.1 with glacial acetic acid. The flow rate was 2.0 ml/min and eluent was monitored at 254 nm. The retention times of butenafine hydrochloride and betamethasone were 4.70 min and 7.76 min, respectively, and the resolution factor was greater than 4.0. Linearity of butenafine hydrochloride and betamethasone were in the range of 100-300 mug/ml and 5-15 mug/ml, respectively. The proposed method is also found to be precise and robust for the simultaneous determination of butenafine hydrochloride and betamethasone in cream formulation.

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