A Validated High-Performance Liquid Chromatographic Method for the Determination of Acebutolol and Diacetolol in Human Plasma

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Abstract
A validated high-performance liquid chromatographic (HPLC) procedure employing ultra-violet (UV) detection for the analysis of acebutolol (Monitan) and its major metabolite, diacetolol, in human plasma in reported. The method is rapid and coupled with standard HPLC procedures leads to a sensitive, accurate, and reproducible assay. The retention times of diacetolol, acebutolol and internal standard, celiprolol, were 4.1, 6.7 and 9.7 minutes, respectively. The peak height versus plasma concentration is linear over the range of 20.0 to 1000 ng/mL for each analyte, with a detection limit of 10.0 ng/mL. The mean absolute recovery of acebutolol and diacetolol using the described assay is 74.6 and 88.8%, respectively. The inter- and intra-day accuracy and precision are within 14.1% of the actual values for all concentrations investigated. Furthermore, this procedure is applied to assess the pharmacokinetics of a single 200 mg oral dose of Monitan.

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