Stability Indicating Fast LC for the Simultaneous Estimation of Intermediates and Degradants of Duloxetine Hydrochloride

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• 作者：Paluru Rudra Mohan Reddy ; J. Sreeramulu ; Petla Y. Naidu and A. Rajasekhara Reddy
• 关键词：Liquid chromatography ; Stability sample analysis ; Drug products ; Duloxetine
• 刊名：Chromatographia
• 出版年：2010
• 出版时间：January, 2010
• 年：2010
• 卷：71
• 期：1-2
• 页码：95-100
• 全文大小：288.6 KB

文摘

A fast, selective and sensitive reversed phase liquid chromatographic method employing a C-18 column has been developed and validated for simultaneous analysis of four impurities of duloxetine hydrochloride, an antidepressant drug, viz., (S)-N,N-dimethyl-3-hydroxy-(2-thienyl)-propanamine, phenolic impurity, 1-napthol and duloxetine succinamide. Good separations were achieved by a gradient elution with mobile phase consisting of a mixture of phosphate buffer 14 mM containing 0.1 % of sodium octanesulfonate, pH 3.0, at a flow rate of 0.8 mL min−1. The detection was at 220 nm. The method was validated for precision, linearity and accuracy. Finally, the developed method was used to quantify the impurities during stability sample analysis of duloxetine hydrochloride drug products.