MEDICAL-SURGICAL JOURNAL-REVISTA MEDICO-CHIRURGICALA, cilt.129, sa.2, ss.459-479, 2025 (ESCI)
When developing a topical formulation, it is essential to evaluate it from the perspective of its carrier capacity for the controlled release of the encapsulated drug. The drug should be simply quantified through an accurate and reproducible method. This paper presents a rapid, simple, sensitive, and reproducible high-performance liquid chromatography method with UV detection for evaluating the ability of chitosan-graft-(3-cyclodextrin/PVA (CS-g-(3-CD/PVA) hydrogels as carriers for the controlled release of vemurafenib (VEM). Materials and methods: The chromatographic separation was achieved using a Waters CORTECS C18 column (100 x 2.1 mm ID, 2.7 mu m). The mobile phase was a mixture of: A (water/formic acid-99.9/0.1, v/v), B (acetonitrile), and C (methanol) in the ratio of 40: 55: 5 (v/v/v). The injection sample amount was 10 mu L, and the run time was 9 minutes in isocratic mode at a flow rate of 1 mL/min. The analyte was detected using UV absorption at 252 nm. Results: The standard calibration curve was linear over the concentration range of 0.78-100 mg/L. The values for LOD and LOQ were 0.5 mg/L and 0.75 mg/L, respectively. The intra-and inter-day precision of measurements were lower than the accepted criteria (RSD <= 2%). The high value of recoveries obtained for VEM indicates that the proposed method was found to be accurate. The stability of VEM solutions was assessed, indicating that the drug remained stable under all relevant conditions. Conclusions: Finally, the validated method was successfully applied to evaluate the ability of chitosan-graft-(3-cyclodextrin/PVA hydrogels to load and sustain release of VEM. The drug entrapment efficiency (DEE%) was between 65 +/- 0.08% and 70 +/- 0.05%.