Validation of a Simple HPLC/UV Method for Assay and In Vitro Release of Glycosaminoglycan from Pharmaceutical Formulations.

ABSTRACT: This study encompasses the validation of a simple, rapid, and sensitive HPLC/UV method developed in accordance with the guidelines set by ICH Q2(R2) for obtaining the active pharmaceutical ingredient from the glycosaminoglycan family in topical formulations. Previous methods reported for analyzing glycosaminoglycans in semisolid formulations are relatively complex and time-consuming, involving extraction, purification, and derivatization. This developed analytical method allows for straightforward extraction of the active pharmaceutical ingredient from the matrix, enabling the direct injection of samples. This method was performed and validated for the assay of the pharmaceutical gel and cream formulations to investigate the parameters of linearity (r = 0.9997 for the gel formulatio

SUBMITTER: Ozgen G 

PROVIDER: S-EPMC11656206 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature