A comprehensive RP-HPLC technique for analyzing disodium edetate and its degradation products in eye drops using AQbD and Six Sigma perspective
Abstract
Abstract The study presents the development of a novel, sustainable, and analytical quality by design (AQbD) driven RP-HPLC method to simultaneously identify disodium edetate in eye drops and its degradation products. The goal of this method is to meet the growing demand for robust, eco-friendly methods of quality control for pharmaceutical products. AQbD ensured method robustness, while minimizing solvent consumption and waste generation to ensure sustainability. Several sustainable tools were investigated to assess their ecological impact in the study. Using Box–Behnken design, three chromatographic parameters were optimized: column oven temperature, flow rate, and buffer pH. An ethanol and tetrabutylammonium hydroxide solution mobile phase at pH 7.0 in gradient mode was found to be optimal. An Avantor Hichrom C18 (4.6 mm × 150 mm, 5 µm) column was used with UV detection at 258 nm and pumped at 1.1 mL/min. The linearity of disodium edetate occurred in the 2–40 μg/mL range with an R 2 of 0.9999. Disodium edetate was subjected to acidic, basic, oxidative, photolytic, and thermal stress conditions in accordance with ICH guidelines. Degradation caused by bases, acids, and oxidation provided the highest degradation rates. Incorporating quality by design principles with sustainability considerations makes this method robust, eco-friendly, and cost-effective for quality control in pharmaceutical products. Having been successfully applied to eye drop formulations, its utility in…
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