Baffinsha S P Ashnah, Ragupathi Vijayageetha, Chanduluru Hemanth Kumar
Department of Pharmaceutical Analysis, C.L Baid Metha College of Pharmacy, Thoraipakkam, Chennai, 6000097, India.
Department of Pharmaceutical Research, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, Chennai, 603203, India.
BMC Chem. 2024 Nov 18;18(1):231. doi: 10.1186/s13065-024-01337-6.
The ternary combination like omeprazole (OMP), amoxicillin (AMX), and rifabutin (RFB) was approved by the FDA in November 2019 for combating Helicobacter pylori infections and ulcers caused by this infection. This study aims to develop and authenticate a robust and eco-friendly RP-UPLC technique aimed at the concurrent analysis of OMP, AMX, and RFB, following ICH guidelines, Analytical Quality by Design (AQbD), and green analytical chemistry (GAC) principles. The analysis used the Thermo C18 column (100 mm × 2.1 mm, 1.7 µm), ethanol, and formic acid solution (43:57) as mobile phase with a flow rate of 0.2 ml/min at 272 nm. The method was developed based on the ICH Q14 and validated according to ICH Q2(R1) followed by Forced degradation studies under various conditions. The method showed good linearity for OMP, AMX, and RFB, with coefficient of determination (r2) of 0.9995, 0.9993, and 0.9997, respectively. Precision studies indicated low %RSD values, confirming high reproducibility. Forced degradation studies confirmed the stability of the drugs for 30 min in acid, base, and redox reactions, and they were also stable for 6 h at 105 °C in dry conditions. GAPI assessment depicted a green and yellow pictogram, AGREE scored 0.85, BAGI scored 80, and RGB12 Whiteness Assessment Tool scored 97.5%. The developed RP-UPLC-PDA technique is robust and reliable for the concurrent quantification of the triple combination. It aligns with sustainability goals, enhancing the efficiency and environmental sustainability of pharmaceutical analysis, and setting a benchmark for future analytical methods.
2019年11月，奥美拉唑（OMP）、阿莫西林（AMX）和利福布汀（RFB）的三联组合被美国食品药品监督管理局（FDA）批准用于对抗幽门螺杆菌感染以及由此感染引起的溃疡。本研究旨在按照国际人用药品注册技术协调会（ICH）指南、设计质量分析（AQbD）和绿色分析化学（GAC）原则，开发并验证一种强大且环保的反相超高效液相色谱（RP-UPLC）技术，用于同时分析OMP、AMX和RFB。该分析采用赛默飞C18色谱柱（100 mm×2.1 mm，1.7 µm），以乙醇和甲酸溶液（43:57）作为流动相，流速为0.2 ml/min，检测波长为272 nm。该方法基于ICH Q14开发，并按照ICH Q2（R1）进行验证，随后在各种条件下进行强制降解研究。该方法对OMP、AMX和RFB显示出良好的线性，测定系数（r2）分别为0.9995、0.9993和0.9997。精密度研究表明相对标准偏差（%RSD）值较低，证实了高重现性。强制降解研究证实了药物在酸、碱和氧化还原反应中30分钟内的稳定性，并且在干燥条件下于105°C下6小时也稳定。绿色分析性能指标（GAPI）评估显示为绿色和黄色象形图，绿色评估（AGREE）得分为0.85，绿色评估指标（BAGI）得分为80，RGB12白度评估工具得分为97.5%。所开发的RP-UPLC-光电二极管阵列（PDA）技术对于三联组合的同时定量分析是强大且可靠的。它符合可持续发展目标，提高了药物分析的效率和环境可持续性，并为未来的分析方法树立了标杆。
