Akademik Veri Yönetim Sistemi
EFES INTERNATIONAL SCIENTIFIC RESEARCH AND INNOVATION CONGRESS, Türkiye, 15 - 16 Eylül 2024, ss.232-245, (Tam Metin Bildiri)
Valacyclovir (VCV) is a synthetic nucleoside analog with antiviral effects. It is used to treat shingles infections, genital herpes, and Herpes simplex on mucous and skin membranes. It is a prodrug with high oral bioresistance and is converted to Acyclovir and valine by a VCV hydrolase enzyme. International and national authorities recommend that the shelf life specification of the finished product should include the identification, content, and quantitation limits of the preservative and the active pharmaceutical ingredient. Although VCV is currently only available in tablet form on the market, there are studies on the development of ocular and oral suspension formulations that may contain preservatives. In this study, an HPLC method that allows the simultaneous determination of VCV with methyl paraben, propyl paraben, the most commonly used preservatives, was developed for the first time. The experimental studies were performed at Abdi Ibrahim Pharmaceuticals’ research laboratories. Chromatographic separation was performed on a Phenomenex Gemini C18 (250.0 mm x 4.6 mm, 5.0 μm) analytical column with a mixture of methanol and orthophosphoric acid solution as the mobile phase. Analyses were performed at a flow rate of 1.0 mL/min with gradient elution and the detection wavelength was set at 250 nm. The linearity ranges were 50.0-600.0 μg/mL for VCV, 2.0-50.0 μg/mL for MP, and 1.0-12.0 μg/mL for PP. The developed method was successfully validated in terms of selectivity, linearity (R2=0.9962), precision (102.4%), accuracy (%95.0-105.0), and robustness. Keywords: Valacyclovir, HPLC, validation, preservatives, determination Funding: This study was funded by the Scientific Research Projects Coordination Unit of Istanbul University. Project number: TYL-2021-37986.