Author(s)
Nihir Hirapara, Dhirendra Kumar Tarai, Dr. Basareddy Chandrasekhar, Dr. Santosh R. Kirtane
- Manuscript ID: 140767
- Volume: 2
- Issue: 7
- Pages: 1–18
Subject Area: Other
Abstract
An eco-green reversed-phase high-performance liquid chromatography (RP-HPLC) method was developed for the quantitative estimation of bortezomib in pharmaceutical dosage forms. Chromatographic separation was achieved using a n C18 reversed-phase column (e.g., 250 mm × 4.6 mm, 5 µm particle size) column with a mobile phase consisting Methanol: Water (0.05% OPA + 0.05% TEA) = 60: 40 v/v (column temperature 35C), delivered at a flow rate of 1 mL/min. Detection was carried out at a wavelength of 280 nm, and bortezomib was eluted at a retention time of 4.5 min. The method was designed following the principles of green analytical chemistry by employing environmentally benign solvents and minimizing solvent consumption and analysis time. The developed method was validated according to regulatory guidelines and showed acceptable linearity over the concentration range of 25-125 μg/mL, along with satisfactory accuracy, precision, specificity, and robustness. Owing to its simplicity, reliability, cost-effectiveness, and reduced environmental impact, the proposed eco-green RP-HPLC method is suitable for routine quality control analysis of bortezomib in pharmaceutical formulations.