Science and Technology Production
Article
Authorship
Laura F. Suchetti
;
Viviana Dabbene
;
TEMPESTI, TOMAS CRISTIAN
;
Carlos G. Ferrayoli
Date
2025
Publishing House and Editing Place
Wiley-VCH GmbH
Magazine
SEPARATION SCIENCE PLUS
Wiley-VCH GmbH
Summary
Information provided by the agent in
SIGEVA
A rapid and stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method with UV detection (210 nm) was developed for the evaluation of chromatographic purity and the analysis of glycerol phenylbutyrate in the pharmaceutical formulation. In this method, a C18 analytical column was used at room temperature with a mobile phase containing a mixture of acetonitrile and water (90:10, v/v) at a flow rate of 1.0 mL/min. The forced degradation study was evaluated accordin...
A rapid and stability-indicating reversed-phase high-performance liquid chromatography (RP-HPLC) method with UV detection (210 nm) was developed for the evaluation of chromatographic purity and the analysis of glycerol phenylbutyrate in the pharmaceutical formulation. In this method, a C18 analytical column was used at room temperature with a mobile phase containing a mixture of acetonitrile and water (90:10, v/v) at a flow rate of 1.0 mL/min. The forced degradation study was evaluated according to the International Conference on Harmonization. The procedure was validated for linearity, accuracy, solution stability, specificity, precision (repeatability and intermediate precision), and robustness in accordance with current guideline requirements and was reported as reliable and suitable for the intended application.
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Key Words
STABILITY INDICATINGGLYCEROL PHENYLBUTYRATEFORCED DEGRADATIONVALIDATIONHPLC