Ergen Harun, Gökekin Yasin, Kartop Remziye Azra, Çetin Ersen Büşra, Güleli Müge, Kocaoba Sevgi, Çalışkan Cem
World Medicine İlaç San. Tic. A.Ş, 15 Temmuz Mah. Camiyolu Cd. No:50, K.4, 34212 Bağcılar, İstanbul, Türkiye.
World Medicine İlaç San. Tic. A.Ş, 15 Temmuz Mah. Camiyolu Cd. No:50, K.4, 34212 Bağcılar, İstanbul, Türkiye; Institute of Graduate Programs, Department of Chemistry, Ankara Hacı Bayram Veli University, Ankara 06500, Turkey.
J Chromatogr B Analyt Technol Biomed Life Sci. 2025 Oct 1;1264:124717. doi: 10.1016/j.jchromb.2025.124717. Epub 2025 Jul 1.
Pharmaceutical products containing glucose and salt are widely used in the health sector and play a vital role. These pharmaceutical products are usually encountered as a part of drugs used in treatment and medical procedures. However, the analytical determination and quantification of active ingredients and impurities belonging to active ingredients in such products is a complicated process. This is because the retention time of impurities belonging to the glucose molecule in these pharmaceutical structures and the presence of salts that give peaks in similar places complicate the analysis process. Moreover, when the British Pharmacopoeia (BP), European Pharmacopoeia (EP) and US Pharmacopoeia (USP) are examined, it is seen that there are only monographs belonging to glucose raw material and there is no record regarding the determination of impurities belonging to glucose in pharmaceutical products containing glucose-salt complex structures. A new method has been developed within the scope of the study to prevent this complexity. As a result of the method development studies, the specific solvent method was optimized and a relatively simple pre-purification process with high recovery was applied to avoid salt interference. In addition, high-precision determination and validation studies of glucose and its impurities were carried out using the High Performance Liquid Chromatography-Refractive Index Detector (HPLC-RID) method. This new analytical approach is expected to contribute to the development of reliable and high-quality products in the healthcare field by raising industry standards.
含有葡萄糖和盐的药品在医疗领域被广泛使用且发挥着至关重要的作用。这些药品通常作为治疗和医疗程序中使用的药物的一部分出现。然而，对此类产品中活性成分及其杂质的分析测定和定量是一个复杂的过程。这是因为这些药物结构中葡萄糖分子杂质的保留时间以及在相似位置产生峰的盐的存在使分析过程变得复杂。此外，在查阅英国药典（BP）、欧洲药典（EP）和美国药典（USP）时发现，仅有葡萄糖原料药的专论，而对于含有葡萄糖 - 盐复合结构的药品中葡萄糖杂质的测定没有相关记录。在该研究范围内开发了一种新方法来避免这种复杂性。通过方法开发研究，优化了特定溶剂法，并应用了回收率高且相对简单的预纯化过程以避免盐的干扰。此外，使用高效液相色谱 - 示差折光检测器（HPLC - RID）方法对葡萄糖及其杂质进行了高精度测定和验证研究。这种新的分析方法有望通过提高行业标准，为医疗保健领域可靠且高质量产品的开发做出贡献。
