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反相高效液相色谱法同时测定乳膏制剂中盐酸布替萘芬和二丙酸倍他米松的含量

RP-HPLC method for simultaneous determination of butenafine hydrochloride and betamethasone dipropionate in a cream formulation.

作者信息

Bhosale Suryakant D, Rajput Sadhana J

机构信息

The Maharaja Sayajirao University of Baroda, Quality Assurance Laboratory, Pharmacy Department, Faculty of Technology and Engineering, Vadodara-390 001, India.

出版信息

J AOAC Int. 2011 Jan-Feb;94(1):106-9.

Abstract

An RP-HPLC method has been developed for the simultaneous determination of butenafine hydrochloride and betamethasone dipropionate on an Inertsil C18 column (250 x 4.6 mm id) using a mobile phase gradient consisting of methanol and water at a flow rate of 1 mL/min. Detection was carried out at 254 nm. Retention times of betamethasone dipropionate and butenafine hydrochloride were 4.82 (+/- 0.80) and 16.18 (+/- 0.17) min, respectively. The method was validated with respect to specificity, linearity, accuracy, precision, ruggedness, and robustness. This method is simple, precise, and sensitive, and applicable for the simultaneous quantification of butenafine hydrochloride and betamethasone dipropionate in a cream formulation.

摘要

已开发出一种反相高效液相色谱法,用于在Inertsil C18柱(250×4.6 mm内径)上同时测定盐酸布替萘芬和二丙酸倍他米松,流动相梯度由甲醇和水组成,流速为1 mL/分钟。检测波长为254 nm。二丙酸倍他米松和盐酸布替萘芬的保留时间分别为4.82(±0.80)分钟和16.18(±0.17)分钟。该方法在特异性、线性、准确度、精密度、耐用性和稳健性方面得到了验证。该方法简单、精确、灵敏,适用于同时定量乳膏制剂中的盐酸布替萘芬和二丙酸倍他米松。

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