Byrne Jonathan, Velasco-Torrijos Trinidad, Reinhardt Robert
Analytical Development Dept., mibe GmbH Arzneimittel, 06796 Brehna, Germany.
Chemistry Dept., National University of Ireland Maynooth, Maynooth, Co. Kildare, Ireland.
J Pharm Biomed Anal. 2014 Aug 5;96:111-7. doi: 10.1016/j.jpba.2014.03.005. Epub 2014 Mar 25.
A novel stability-indicating reversed phase high performance liquid chromatographic (RP-HPLC) method for the simultaneous assay of betamethasone-17-valerate, fusidic acid and potassium sorbate as well as methyl- and propylparaben in a topical cream preparation has been developed. A 100mm×3.0mm ID. Ascentis Express C18 column maintained at 30°C and UV detection at 240nm were used. A gradient programme was employed at a flow-rate of 0.75ml/min. Mobile phase A comprised of an 83:17 (v/v) mixture of acetonitrile and methanol and mobile phase B of a 10g/l solution of 85% phosphoric acid in purified water. The method has been validated according to current International Conference on Harmonisation (ICH) guidelines and applied during formulation development and stability studies. The procedure has been shown to be stability-indicating for the topical cream.
已开发出一种新型的稳定性指示反相高效液相色谱（RP-HPLC）方法，用于同时测定局部乳膏制剂中的倍他米松-17-戊酸酯、夫西地酸、山梨酸钾以及对羟基苯甲酸甲酯和丙酯。使用内径为3.0mm、长度为100mm的Ascentis Express C18柱，柱温保持在30°C，紫外检测波长为240nm。采用梯度洗脱程序，流速为0.75ml/min。流动相A由乙腈和甲醇按83:17（v/v）混合而成，流动相B为85%磷酸在纯水中的10g/l溶液。该方法已根据当前国际协调会议（ICH）指南进行了验证，并应用于制剂开发和稳定性研究。该方法已被证明对局部乳膏具有稳定性指示作用。
