(S)-oxiracetam is undergoing clinical trials as an active ingredient in the racemic oxiracetam. Here, we report a specific analytical method for analyzing (S)-oxiracetam and four related impurities in the bulk drug of (S)-oxiracetam by using high-performance liquid chromatography (HPLC) system. The chromatographic system included a Capcell pak NH2 analytical column, a mobile phase containing acetonitrile-water (95:5, v/v; pH adjusted to 2.0 with trifluoroacetic acid) at a flow rate of 1.0 mL/min, column temperature at 35 ℃ and the UV detection wavelength is set at 210 nm. This analytical method has shown effective and specific analysis for (S)-oxiracetam and four related substances. Moreover, the molecular weight and chemical structure preliminarily speculated of related substances were characterized by mass spectrometry. The methodology was verified by HPLC and results collected of the method validation included the system suitability, specificity sensitivity, linearity and accuracy, good linear correlation coefficient R2 was more than 0.9991. The analytical method developed and verified in the study, as far as we know, is the most exhaustive HPLC determination report which could be applied for the quality control and stability monitor purposes of the bulk drug of (S)-oxiracetam in the routine pharmaceutical analysis.

中文翻译：

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使用HPLC分析（S）-奥拉西坦的原料药中的（S）-奥拉西坦和四种相关物质。

（S）-奥拉西坦作为消旋奥拉西坦的有效成分正在接受临床试验。在这里，我们报告了一种使用高效液相色谱（HPLC）系统分析（S）-奥拉西坦原料药中的（S）-奥拉西坦和四种相关杂质的特定分析方法。色谱系统包括一个Capcell pak NH2分析柱，一个流动相，其中包含乙腈-水（95：5，v / v； pH用三氟乙酸调节至2.0），流速为1.0 mL / min，柱温为35℃紫外线检测波长设定为210nm。该分析方法显示出对（S）-奥拉西坦和四种相关物质的有效而具体的分析。此外，通过质谱法对相关物质的初步推测的分子量和化学结构进行了表征。该方法已通过HPLC验证，所收集的方法验证结果包括系统适用性，特异性敏感性，线性和准确性，良好的线性相关系数R2大于0.9991。据我们所知，研究中开发和验证的分析方法是最详尽的HPLC测定报告，可用于常规药物分析中（S）-奥拉西坦原料药的质量控制和稳定性监测目的。