A novel HPLC-UV method for determining alendronate in rat plasma through precolumn derivatization with phenyl isothiocyanate: Application to pharmacokinetics |
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Authors: | Yu Wang Jing Yang Yanfang Guo Haipeng Wang Yalan Liu Huiming Huang |
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Affiliation: | 1. School of Pharmacy, Nanchang University, Nanchang, P. R. China;2. Department of Chemical Analysis, Jiangxi Institute for Drug Control, Nanchang, P. R. China |
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Abstract: | The determination of alendronate (ALE) in biofluids using a low-cost instrument is potentially useful in preclinical pharmacokinetic studies. This study developed and validated a high-performance liquid chromatography with ultraviolet method for ALE determination in rat plasma using precolumn derivatization with phenyl isothiocyanate (PITC). Inhibiting compounds in the samples were first eliminated using solid-phase extraction. ALE in the sample was subsequently allowed to react with PITC to form a phenylthiocarbamoyl derivative for further analysis. The assay was linear within the concentration range of 0.29–25.0?µg/mL. The precision and accuracy were less than 3.9% and 98.0?±?3.9%, respectively. The limits of detection and quantification were 0.08 and 0.20?µg/mL, respectively. The method was successfully used to evaluate the pharmacokinetic parameters of ALE in rats following a single oral administration (30.0?mg/kg). The results show that the peak plasma ALE concentration is 0.69?±?0.18?µg/mL. The area under the plasma concentration–time curve value of ALE was 2.14?±?0.68?µg/mL hr. This method can suitably evaluate the bioavailabilities of different ALE dosage forms in preclinical pharmacokinetic studies. |
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Keywords: | Alendronate HPLC-UV method pharmacokinetics phenyl isothiocyanate precolumn derivatization |
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