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This randomized trial assesses naltrexone levels in healthy volunteers, indicating effective quantification methods.
A simple and reliable reversed-phase high-performance liquid chromatographic method with coulo-metric detection is described for the quantitation of naltrexone and its metabolite, 6-beta-naltrexol, in plasma samples of healthy volunteers who received orally 50 mg of naltrexone. The analytes and the internal standard, naloxone, are extracted with an octadecyl solid-phase extraction column before chromatography. The mobile phase is 0.01 M potassium phosphate (pH 3)-acetonitrile (85:15, v/v) and it is pumped at 0.8 ml/min. The coulometric detector is formed by two electrodes set at +0.20 V and +0.70 V, with a palladium reference electrode. The limit of quantitation observed was 5 ng/ml for both naltrexone and 6-beta-naltrexol. This method can be used to investigate pharmacokinetic parameters of different pharmaceutical preparations of this opioid antagonist.
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P et al. (1991) studied this question.
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