El-Hanboushy Sara, M Marzouk Hoda, S Ayish Nada
Pharmaceutical Chemistry Department, Faculty of Pharmacy, Future University in Egypt, Cairo, 11835, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini street, Cairo, 11562, Egypt.
Sci Rep. 2025 Jul 2;15(1):22724. doi: 10.1038/s41598-025-07502-8.
Epilepsy is a chronic neurological disease that affects the brain and causes a recurrent seizure. This condition affects a lot of people worldwide making it a global neurological disorder. The first line for managing epilepsy, is the use of Anti-epileptic drugs. Herein, a reliable and ecological chromatographic method was developed, verified and validated for the simultaneous determination of three approved drugs that can be co-administered in many treatment protocols for epilepsy management; Piracetam (PIR), Gabapentin (GBP) and Levetiracetam (LEV). The developed method was founded on high performance liquid chromatography (HPLC-UV). Separation was accomplished using a 5.0 μm particle size, 250 × 4.6 mm Inertsil ODS-3 C column with the UV detection set at 210.0 nm. An isocratic elution system was employed, consisting of a mixture of methanol and water in a ratio of 15:85 (v/v) at ambient temperature. The developed method demonstrated linearity throughout a range of concentration of 30.0-1000.0 µg/mL for GBP and 10.0-100.0 µg/mL for LEV and PIR. The suggested method was optimized and validated following the guidelines stated by the ICH and was utilized for the determination of the aforementioned drugs in their respective pharmaceutical formulation. Moreover, the supremacy of the developed method was further extended for monitoring the in-vitro release profile of the stated drugs and content uniformity of their marketed pharmaceutical formulations. Finally, the ecological impact of the suggested method was monitored, evaluated and compared to the official HPLC ones utilizing newly introduced greenness, blueness and whiteness assessment methods tools.
癫痫是一种影响大脑并导致反复发作的慢性神经疾病。这种疾病在全球影响着众多人群,使其成为一种全球性神经障碍。癫痫管理的一线方法是使用抗癫痫药物。在此,开发、验证并确认了一种可靠且环保的色谱方法,用于同时测定三种已获批的药物,这三种药物可在许多癫痫管理治疗方案中联合使用;即吡拉西坦(PIR)、加巴喷丁(GBP)和左乙拉西坦(LEV)。所开发的方法基于高效液相色谱法(HPLC - UV)。使用粒径为5.0μm、250×4.6mm的Inertsil ODS - 3 C柱进行分离,紫外检测波长设定为210.0nm。采用等度洗脱系统,由甲醇和水按15:85(v/v)的比例在室温下混合而成。所开发的方法在GBP浓度范围为30.0 - 1000.0μg/mL、LEV和PIR浓度范围为10.0 - 100.0μg/mL内均呈现线性。按照国际人用药品注册技术协调会(ICH)规定的指南对所建议的方法进行了优化和验证,并用于测定上述药物在各自药物制剂中的含量。此外,所开发方法的优势进一步扩展到监测所述药物的体外释放曲线及其市售药物制剂的含量均匀度。最后,利用新引入的绿色度、蓝色度和白色度评估方法工具,对所建议方法的生态影响进行了监测、评估并与官方HPLC方法进行了比较。