Ethanol Content Determination in Medicine Syrups Using Headspace and Multidimensional Heart-Cut Gas Chromatography Coupled to Mass Spectrometry

Despite the efforts of the pharmaceutical industry to reduce the ethanol content in medicines, many of these products are still commercially available. These medicines must be monitored by quality control techniques using accurate method. Therefore, this study proposes to develop and validate an analytical method for ethanol quantification in adult and pediatric syrups, in order to guarantee the safety of medication certificates. For this, headspace multidimensional gas chromatography (heart-cut) coupled to mass spectrometry (HS-MDGC/MS) was used. The method was validated according to the norm established by National Agency of Sanitary Surveillance (ANVISA) presenting limit of detection (LOD) of 0.03% (v/v) and limit of quantification (LOQ) of 0.06% (v/v) ethanol, excellent selectivity and the recovery values (accuracy) were between 96.71 and 101.38%. Ethanol concentrations in commercial medicines syrups varied from 0.06 to 8.83%, which makes evident the need to control the syrup producing industries.

尽管制药行业始终致力于降低药品中的乙醇含量，但目前仍有大量此类产品在市场上流通。此类药品需采用精准的质量控制方法开展监测工作。因此，本研究旨在开发并验证一种可用于成人及儿科糖浆中乙醇定量分析的方法，以保障药品的质量安全。本研究采用带中心切割的顶空多维气相色谱-质谱联用法（HS-MDGC/MS）完成实验。该方法按照巴西国家卫生监督局（National Agency of Sanitary Surveillance, ANVISA）制定的规范完成验证，其乙醇检出限（limit of detection, LOD）为0.03%（体积比），定量限（limit of quantification, LOQ）为0.06%（体积比），选择性优异，回收率（准确度）介于96.71%至101.38%之间。市售糖浆类药品的乙醇含量范围为0.06%至8.83%，由此可见，对糖浆生产企业实施有效监管实属必要。