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: 0.48). 09/2009; 71(5):547-51. DOI: 10.4103/0250-474X.58194
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.
Conference Paper: Analysis of a nonlinear transmission line
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ABSTRACT: A critical review of the literature of the analysis of steroid hormone drugs is presented based on 213 publications published between 2004 and 2010. The state of the art of the assay and purity check of bulk drug materials is characterized on the basis of the principal pharmacopoeias supplemented by the literature dealing with their impurity profiling and solid state characterization. The determination of the active ingredients and impurities/degradants in pharmaceutical formulation by HPLC, other chromatographic, electrodriven, spectrophotometric and other methods is also summarized. A short section deals with the application of analytical methods in drug research. The literature of the determination of steroid hormones in environmental samples is summarized in tabulated form.
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ABSTRACT: An HPLC/MS/MS method for determination of butenafine hydrochloride in human plasma with testosterone propionate as the internal standard (IS) was developed and validated. Plasma samples were extracted with an n-hexane/diethyl ether (1:2, v/v) mixture and separated using a C(18) column by a gradient elution with the mobile phase containing acetonitrile and 5mM ammonium acetate buffer. Quantification was performed using multiple reaction monitoring (MRM) mode with transition of m/z 318.4→141.0 for butenafine hydrochloride and m/z 345.5→97.0 for testosterone propionate (IS). This method was validated in terms of specificity, linearity, precision, accuracy, and stability. The lower limit of quantification (LLOQ) of this method was 0.0182 ng/ml and the calibration curve was linear over the 0.0182-1.82 ng/ml. The intra- and inter-run coefficient of variance was less than 11.53% and 10.07%, respectively. The samples were stable under all the tested conditions. The method was successfully applied to study the pharmacokinetics of butenafine hydrochloride in healthy Chinese volunteers following its topical administration.
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