Drug Development and Industrial Pharmacy 2008-12-01

High-performance liquid chromatographic determination of flavoxate hydrochloride and its hydrolysis product.

Alaa el-Gindy, Randa A Abdel-Salam, Shehab Sallam

Index: Drug Dev. Ind. Pharm. 34(12) , 1311-22, (2008)

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Abstract

Liquid chromatographic method was presented for the determination of flavoxate hydrochloride (FX) and its hydrolysis product. The method was based on high-performance liquid chromatographic (HPLC) separation of FX from its hydrolysis product on CN column using a mobile phase consisting of acetonitrile-12 mM ammonium acetate (45:55, vol/vol, pH 4.0) with UV detection at 220 nm and flow rate of 1.5 mL min(-1). The proposed HPLC method for the determination of FX was utilized to investigate the kinetics of acidic hydrolytic process at different temperatures and to calculate its activation energy. In addition, the proposed HPLC method was used for pH-rate profile study of hydrolysis of FX in Britton-Robinson buffer solutions. The 3-methylflavone-8-carboxylic acid ethyl ester, as impurity of flavoxate hydrochloride, can be separated by the proposed HPLC method.