A Stability-Indicating Simultaneous Analysis of Acetaminophen and Hydrocodone Bitartrate in Tablets Formulation by HPLC

Abstract

Abstract A rapid, simple, stability indicating, reversed phase high-performance liquid chromotographic (HPLC) method is presented here for direct and simultaneous quantitation of Acetaminophen and Hydrocodone Bitartrate in tablets dosage form at a ratio of 100:1. This procedure not only separated the two active components but also separated known impurity and degradation product of acetaminophen, p-aminophenol and p-chloroacetanilide. The method described here also separates other opiates, codeine sulfate and hydromorphone. In this procedure a radial pak cartridge packed with chemically bonded octadecylsilane (C18, 4 micron) as a stationary phase and (16:84) acetonitrile with phosphate buffer (pH 3.3) as the mobile phase were utilized. Detection was made with a uv-spectrophotometer at 215 nm. Quantitation was performed by peak height and external standard method. The average recovery at 100% label claim and the relative standard deviation of the two respective components, acetaminophen and hydrocodone were: 99.03%, 1.29% and 98.78%, 0.3%.