Article

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: 0.34). 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.

1 Bookmark
 · 
95 Views
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: A simple, sensitive, rapid and accurate spectrophotometric method was developed and validated for the estimation of betamethasone in bulk and pharmaceutical dosage forms. The method was based on the formation of bluish green chromophore with 0.04 % of sodium dichromate and concentrated sulphuric acid showing the absorption at 615 nm. The proposed method has permitted the quantification of betamethasone over linearity in the range of 5 -30 µg/mL. The method was validated as per ICH guidelines. INTRODUCTION Betamethasone is chemically, (8S,9R,10S,11S,13S,14S,16S ,17R)-9-fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta [a]phenanthren-3-one having the chemical formula C 22 H 29 FO 5 with average molecular weight 392.4611. It is a synthetic glucocorticoid used topically as an anti inflammatory and administered orally as a replacement therapy for adrenal insufficiency. Betamethasone and its derivatives: betamethasone sodium phosphate and betamethasone acetate are used as anti inflammatory and immunosuppressant agents. Betamethasone is combined with a mineralocorticoid to manage adrenal insufficiency and is used in the form of betamethasone benzoate, betamethasone dipropionate or betamethasone valerate for the treatment of inflammation due to corticosteroid-responsive dermatoses. Betamethasone and clotrimazole are used together to treat cutaneous tinea infections 1 . The official methods for determination of betamethasone dipropionate in different pharmaceutical dosage forms were prescribed in the United States Pharmacopoeia (USP). Past studies showed different analytical methods of betamethasone using spectrophometry 2,3 , voltammery in biological fluids 4 , HPLC 5-9 , stability studies 10,12 , reverse phase sequential injection chromatography 13 and LC-MS 14 . Estimation of betamethasone was performed in human plasma 15 , milk 16 and urine 17 . The determination of related substances was reported for betamethasone alone and in combination with other drugs of marketed formulations 18 . In the present communication, we have developed a simple visible spectroscopic method with considerable precision, accuracy and sensitivity for the estimation of betamethasone in bulk and pharmaceutical dosage forms at 615 nm wavelength.
    Journal of Pharmaceutical and Scientific Innovation (JPSI). 10/2013; 2(5):13-15.
  • [Show abstract] [Hide abstract]
    ABSTRACT: First Page of the Article
    Solid-State Circuits Conference. Digest of Technical Papers. 1961 IEEE International; 03/1961
  • [Show abstract] [Hide abstract]
    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.
    Journal of pharmaceutical and biomedical analysis 11/2010; 55(4):728-43. · 2.45 Impact Factor