ACS omega · 2025
Development and Validation of an Eco-Friendly HPLC Stability-Indicating Technique for Quantification of Atropine Sulfate and Benzyl Alcohol in Raw and Injectable Solutions.
СтатьяНазвание и аннотация: Перевод в очереди
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Darwish Ahmed Sobhy, M Abdel-Raheem Sherief, M A Meligy Ahmed, Ibrahim Al-Sultan Saad, Kandeel Mahmoud, Darwish Wageh Sobhy
Аннотация
Our study aimed to design and validate an affordable and ecologically conscious white HPLC stability-indicating method that can simultaneously detect atropine sulfate and benzyl alcohol in both bulk and injectable solutions of a generic medication from EIPICO, specifically for the registration of Trophovet injection, which is used in veterinary prescriptions. At a flow rate of 0.7 mL/min, the mobile phase consisted of 700 mL of 0.025 M potassium phosphate monobasic buffer solution with a pH of 3.5 and 300 mL of ethanol. Atropine sulfate concentrations ranged from 24 to 240 μg mL-1, whereas benzyl alcohol concentrations ranged from 600 to 6000 μg mL-1. The detection wavelength was 225 nm, the injection volume was 20 μL, and the analysis runtime was <7 min. The conclusional AES of 90, the AGREE of 0.73, the MoGAPI of 76 with six green parts, the BAGI score of 80, and the whiteness of 99.2 all showed how environmentally friendly the procedure was. The approach being offered has remarkable qualities such as cost-effectiveness, ecological sustainability, and compliance with ICH and US FDA standards validation items.