Ankam R, Mukkanti K, Durgaprasad S, Khan M
Glenmark Pharmaceuticals Ltd, R&D Centre, Plot No. C-152, MIDC, Malegaon, Sinnar-422 113, India.
Indian J Pharm Sci. 2009 Sep;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.
建立了一种快速、特异、准确且精密的反相高效液相色谱法，用于同时测定乳膏制剂中盐酸布替萘芬和倍他米松的含量。测定在Licrocart Licrosphere RP-select B（250×4.6 mm，5μm）柱上以等度洗脱模式进行，流动相由50 mM醋酸铵缓冲液和乙腈按60:40的比例组成，用冰醋酸调节pH至4.5±0.1。流速为2.0 ml/min，在254 nm波长处监测洗脱液。盐酸布替萘芬和倍他米松的保留时间分别为4.70分钟和7.76分钟，分离度大于4.0。盐酸布替萘芬和倍他米松的线性范围分别为100 - 300μg/ml和5 - 15μg/ml。该方法对于同时测定乳膏制剂中的盐酸布替萘芬和倍他米松也具有精密性和稳健性。
