Sulthiame is an old antiepileptic medicine with controversial history, whose effectiveness and safety in use have been stated in some current studies. However, there is still a need for further clinical examinations for confirmation of its usefulness and tolerability in monotherapy and add‐on therapy for epilepsy of various etiologies. A fully validated RP HPLC–UV method for determination of sulthiame in serum/plasma samples using desethylatrazine as the internal standard was developed. The biological fluid was prepared for analysis by a simple precipitation method with acetonitrile. The following validation parameters of the method were determined: selectivity/specificity, linearity range (0.2–50.0 μl/ml, R² > 0.9999), limits of detection (0.19 μl/ml) and quantification (0.58 μl/ml), precision (intra‐day CV 1.06% and inter‐day CV 1.25%), extraction recovery (~100%), accuracy (bias, −4.61–0.80%), carryover and ruggedness. Moreover, the stability of the medicine in plasma samples under different storage conditions was also tested. The usability of the method for clinical examinations was checked by analysis of serum samples originating from 19 patients treated with sulthiame. The proposed method is appropriate for determination of sulthiame in serum/plasma samples for drug monitoring purposes, as well as for pharmacokinetic studies.

中文翻译：

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经过完全验证的HPLC-UV方法测定人血清/血浆样品中的硫磺

Sulthiame是一种古老的抗癫痫药，具有争议的历史，目前的一些研究已经证明了其使用的有效性和安全性。但是，仍然需要进一步的临床检查，以确认其在各种病因性癫痫的单一疗法和附加疗法中的有效性和耐受性。开发了一种完全验证的RP HPLC-UV方法，以去乙基阿特拉津为内标，用于测定血清/血浆样品中的硫磺。通过简单的乙腈沉淀法制备了用于分析的生物流体。确定了该方法的以下验证参数：选择性/特异性，线性范围（0.2-50.0μl/ ml，R ² > 0.9999），检出限（0.19μl/ ml）和定量（0.58μl/ ml），精密度（日内CV 1.06％和日间CV 1.25％），提取回收率（〜100％），准确度（偏差，−4.61-0.80％），残留和坚固性。此外，还测试了药物在不同储存条件下在血浆样品中的稳定性。通过分析源自19名接受sulthiame治疗的患者的血清样本，检查了该方法在临床检查中的可用性。所提出的方法适用于测定血清/血浆样品中的磺胺类药物，以进行药物监测以及进行药代动力学研究。