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Abstract

Simultaneous HPLC determination of butenafine hydrochloride and betamethasone in a cream formulation

Author(s): R Ankam1, K Mukkanti2, S Durgaprasad3, M Khan1
1 Glenmark Pharmaceuticals Ltd, R&D Centre, Plot No. C-152, MIDC, Malegaon, Sinnar-422 113, India 2 Centre for Environment IPGSR, JNT University, Hyderabad-500 028, India 3 Indian Immunologicals Ltd, Rakshapuram, Gachibowli, Hyderabad-500 019, India

Correspondence Address:
R Ankam Glenmark Pharmaceuticals Ltd, R&D Centre, Plot No. C-152, MIDC, Malegaon, Sinnar-422 113 India [email protected]


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 (250Χ4.6 mm, 5 Î?) 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 μg/ml and 5-15 μg/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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