ファーマシューティカ アナリティカ アクタ

概要

Utility of Synchronous Spectrofluorimetric Method for Rapid Selective Determination of Bimatoprost: Stress Stability Study and Green Analytical Application

Mohammed W, Safaa T, Abou El-Alamin MM, Nahla NS and Elabd MA

Stability indicating Synchronous spectrofluorimetric (SF) method has been proposed and validated for the determination of bimatoprost in presence of its acid, base, and oxidative degradation products by measuring SF at 272 nm using delta lamba (∆λ)=30 nm in water. Bimatoprost was subjected to stress conditions of 2 M HCL, 2 M NaoH and 30% H₂O₂ . The identification of degradation products were done by LC-MS. The pathway of degradation was postulated. The effect of different experimental parameters on the fluorescence of the drug was studied and optimized. The range of linearity was over 25-250 ng/mL, the detection limit of 0.005 ng/ mL, and quantitation limit of 0.018 ng/ mL for bimatoprost. The developed method was validated according to ICH guidelines. The accuracy was checked by applying the proposed method for the determination of the drug and it’s degradant. The mean recoveries percentages were found to be 99.39 ± 1.08. RSD values for precision (repeatability and intermediate) testing was 0.569 and 1.28 respectively. The developed method was applied effectively for analysis of the drug in its ophthalmic formulation. The developed method was statistically compared with the reported method revealing high accuracy with good precision. The suggested method was found to be a green analytical chemistry method; the solvent used is water and hence that method can be suitable for routine analysis of the studied drug without effecting the environment harmfully