Abstract

Abstract The high-performance liquid chromatographic (HPLC) method presented is a simple and rapid analytical procedure for the determination of hydrocodone in Tussionex Pennkinetic® extended-release suspension in the presence of chlorpheniramine and several excipients. Hydrocodone was extracted and separated from the suspension with methylene chloride under alkaline pH conditions. Sample recoveries were from 99.6 to 104.3%. Satisfactory resolution was obtained using a C8 column (Alltech 10μM, 25-cm by 4.6-mm inside diameter) and a mobile phase consisting of acetonitrile buffered at pH 4.5 (0.01M KH2PO4 and 0.05M KNO3) maintaining a flow rate of 1.4 mL/min. Corresponding run time for the complete separation of hydrocodone was around 14 min. The method was used to determine the concentration of HCD in five Tussionex® extended-release suspension samples that have been tampered with and in one control sample.

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