采用创新的反相高效液相色谱（RP-HPLC）技术对药品中加巴喷丁和甲钴胺进行平行定量的绿色与白色分析方法。
Green and white analytical approach for parallel quantification of gabapentin and methylcobalamin in medicinal products using inventive RP-HPLC technique.
作者信息
Mahgoub Samar M, Alminderej Fahad M, Binsaleh Ammena Y, Alsehli Bandar R, Saleh Sayed M, Mohamed Mahmoud A
机构信息
Materials Science and Nanotechnology Department, Faculty of Postgraduate Studies for Advanced Sciences, Beni-Suef University, Beni-Suef, Egypt.
Department of Chemistry, College of Science, Qassim University, Buraidah, 51452, Saudi Arabia.
出版信息
Sci Rep. 2025 Jun 23;15(1):20263. doi: 10.1038/s41598-025-07056-9.
A simple, selective, and environmentally sustainable RP-HPLC method was developed for simultaneous quantification of gabapentin (GAB) and Methylcobalamin (MET) in pharmaceutical products. Separation was achieved on a Zorbax Eclipse C8 column (150 × 4.6 mm, 3.5 μm) using a green mobile phase of potassium phosphate buffer (pH 6.9)/acetonitrile (95:5 v/v) at 2.0 mL/min, with detection at 210 nm. Total analysis time was 10 min with 100 µL injection volume. The method showed excellent linearity (3-50 µg/mL; R² > 0.9998), LODs (0.60-0.80 µg/mL), and LOQs (2.00-2.50 µg/mL). Environmental sustainability was validated by multiple metrics: AGREE (0.70), AGREEprep (0.71), and Analytical Eco-Scale (80), confirming superior greenness. Forced degradation studies demonstrated stability-indicating capability per ICH guidelines. This eco-friendly approach provides a reliable solution for quality control of GAB/MET formulations while minimizing environmental impact.
开发了一种简单、选择性好且环境可持续的反相高效液相色谱（RP-HPLC）方法，用于同时定量药品中的加巴喷丁（GAB）和甲钴胺（MET）。采用Zorbax Eclipse C8柱（150×4.6 mm，3.5 µm），以磷酸钾缓冲液（pH 6.9）/乙腈（95:5 v/v）的绿色流动相，流速为2.0 mL/min，在210 nm波长处进行检测，实现分离。进样体积为100 µL时，总分析时间为10分钟。该方法具有出色的线性（3-50 µg/mL；R²>0.9998）、检测限（0.60-0.80 µg/mL）和定量限（2.00-2.50 µg/mL）。通过多种指标验证了环境可持续性：AGREE（0.70）、AGREEprep（0.71）和分析生态尺度（80），证实了其卓越的绿色程度。强制降解研究表明该方法符合国际人用药品注册技术协调会（ICH）指南的稳定性指示能力要求。这种环保方法为GAB/MET制剂的质量控制提供了可靠的解决方案，同时将环境影响降至最低。
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