Determination of Oxycodone Content and Related Substances in Oxycodone and Acetaminophen Capsule by High-performance Liquid Chromatography

نویسندگان

  • Liandong Hu
  • Yanjing Shi
چکیده

A selective, rapid and sensitive high-performance liquid chromatography (HPLC) method has been developed for the simultaneous determination of oxycodone and related substances in oxycodone and acetaminophen capsule. An isocratic elution was performed to determine content of oxycodone on a Welchrom C18 column (5μm, 250 ×4.6 mm) for the separation, with 7mM potassium dihydrogen phosphate aqueous solution (containing 0.1% phosphoric acid, 0.1% n-nonylamine, with potassium hydroxide solution (1 → 2), the pH was adjusted to 4.9 ± 0.1) and methanol (9:1) as the mobile phase at the flow rate of 1 mL/min.The detection wavelength for oxycodone was 214 nm. The accuracy of this method, measured by the recovery of oxycodone was above 99% at three spiking levels. The linear regression analysis data for the calibration.plots showed good linear relationship at the concentration range. Gradient elution was used in order to assay the contents of related substances at the detection wavelength of 230nm. All the parameters of recovery study were within the limits. Both of the two methods showed good linearity for oxycodone and related substances, respectively. The main component oxycodone was well separated from other ingredients and degradation products. Both of the two methods were capcable to confirm the contents of corresponding substances. This method is fast, simple, and can be used for determination of oxycodone and related substances in this oxycodone and acetaminophen preparation.

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تاریخ انتشار 2015