Long-Term Stability of Nelfinavir Mesylate in Human Plasma

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Abstract
Nelfinavir mesylate (NFV) is an HIV protease inhibitor approved for the treatment of HIV infection. Since its introduction, NFV has become a common component of standard highly active antiretroviral regimens. Although the drug has been available since 1997, the pharmacokinetic and pharmacodynamic properties of NFV and its active hydroxy-t-butylamide (M8) metabolite have not been well characterized. We recently completed investigations into the stability of NFV and M8 in plasma stored at −20 and −70 °C for up to 19 months. We observed significant degradation of both compounds in heparinized plasma samples stored at −20 °C. These results may have implications for those involved with the collection and analysis of NFV and M8 pharmacokinetic data.