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 (250×4.6 mm, 5 μ) 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.
Highlights
Optimization of mobile phase was performed based on resolution, total runtime, asymmetric factor and theoretical plates obtained for butenaÞne hydrochloride and betamethasone
Mobile phase consisting of 50 mM ammonium acetate buffer and acetonitrile in the ratio of 60:40, adjusted pH 4.5±0.1 with glacial acetic acid was selected which gave sharp, well resolved peaks for butenafine hydrochloride and betamethasone
UV spectra of butenaÞne hydrochloride and betamethasone showed that both the drugs absorbed appreciably at 254 nm, so the same was selected as the detection mV
Summary
Linearity and range Regression coefÞcient (r2) Regression equation (y=mx+c)* Accuracy Precision (RSD, n=6) SpeciÞcity Stability analytical solution (normal conditions) Stability of analytical solution (In dark refrigerator) Intermediate precision (RSD). RSD = Relative Standard Deviation, y = peak area, x = concentration in μg/ml, m = slope, c = intercept and sample solutions were observed at 25+20 for 24 h. The sample solution was assayed at every 6 h intervals up to 24 h. Optimization of mobile phase was performed based on resolution, total runtime, asymmetric factor and theoretical plates obtained for butenaÞne hydrochloride and betamethasone. Mobile phase consisting of 50 mM ammonium acetate buffer and acetonitrile in the ratio of 60:40, adjusted pH 4.5±0.1 with glacial acetic acid was selected which gave sharp, well resolved peaks for butenafine hydrochloride and betamethasone The retention time for butenafine hydrochloride and betamethasone were 4.7 and 7.7 min, respectively. The asymmetry factor for butenafine hydrochloride and betamethasone were 1.3, 1.1, respectively. UV spectra of butenaÞne hydrochloride and betamethasone showed that both the drugs absorbed appreciably at 254 nm, so the same was selected as the detection mV
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
