Development and validation of reversed phase high performance liquid chromatography method for determination of dexpanthenol in pharmaceutical formulations
Development and validation of reversed phase high performance liquid chromatography method for determination of dexpanthenol in pharmaceutical formulations
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DOI：
10.1016/j.jpba.2006.09.021
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发表时间：
2007-02-19
影响因子：
3.4
通讯作者：
Zinchenko, A. A.
中科院分区：
文献类型：
--
作者：
Kulikov, A. U.;Zinchenko, A. A.
本文介绍了用等密度高效液相色谱法测定气雾剂和凝胶中葡聚糖醇含量的方法。方法采用Vydac蛋白C4色谱柱，流动相为三氟乙酸水溶液，206nm紫外检测。在13.0 ~ 130 μ g mL（-1）范围内呈线性关系（r = 0.9999）。方法回收率好，日内、日间相对标准偏差均小于1.0%。并确定了特异性、准确性和鲁棒性等验证参数。该方法可用于泛醇气雾剂和凝胶的泛醇醇测定，因为该方法可将泛醇从气雾剂或凝胶辅料中分离出来。(c) 2006 Elsevier B.V.版权所有
This paper describes the validation of an isocratic HPLC method for the assay of dexpanthenol in aerosol and gel. The method employs the Vydac Proteins C4 column with a mobile phase of aqueous solution of trifluoroacetic acid and UV detection at 206 nm. A linear response (r > 0.9999) was observed in the range of 13.0-130 mu g mL(-1). The method shows good recoveries and intra and inter-day relative standard deviations were less than 1.0%. Validation parameters as specificity, accuracy and robustness were also determined. The method can be used for dexpanthenol assay of panthenol aerosol and gel with dexpanthenol as the method separates dexpanthenol from aerosol or gel excipients. (c) 2006 Elsevier B.V. All rights reserved.