Simultaneous Determination of Acetaminophen and Hydrocodone Bitartrate in Solid Dosage Forms by HPLC

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Abstract
A reversed-phase, high performance liquid chromatographic method is developed and validated for the simultaneous determination of acetaminophen and hydrocodone bitartrate in pharmaceutical dosage forms. The method employs a Radialpak Cyanopropylsilane Cartridge with a mobile phase containing water, acetonitrile and dibutylamine phosphate (90:10:1). The detection is carried out using a variable wavelength UV-detector set at 215 nm. The acetaminophen showed linearity from 2.0 to 8.0 mg/mL range with a correlation coefficient of 0.999. The hydrocodone bitartrate showed linearity from 0.020 to 0.080 mg/mL range with a correlation coefficient of 0.999. Recoveries for acetaminophen averaged about 100.2% and hydrocodone bitartrate about 102.0% with a standard deviation of about 2.0%. System suitability showed excellent resolution of major peaks. The method is suitable for composite, content uniformity and dissolution assay of capsules and tablets.

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