Open AccessVALIDATION OF A BIOANALYTICAL REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR THE QUANTITATION OF NYSTATIN IN AN ANIMAL MODEL AFTER INTRANASAL IN SITU GEL ADMINISTRATION
Author(s) -
Marzuka Kazi,
Mohamed Hassan Dehghan
Publication year - 2020
Publication title -
asian journal of pharmaceutical and clinical research
Language(s) - English
Resource type - Journals
eISSN - 2455-3891
pISSN - 0974-2441
DOI - 10.22159/ajpcr.2020.v13i10.39229
Subject(s) - chromatography , bioanalysis , nystatin , high performance liquid chromatography , pharmacokinetics , nasal administration , chemistry , calibration curve , methanol , phase (matter) , detection limit , pharmacology , medicine , antibiotics , biochemistry , organic chemistry
Objective: The aim of the study was to develop and validate a bioanalytical reverse-phase high-performance liquid chromatographic (HPLC) method for the estimation of nystatin in rat plasma after intranasal administration.
Methods: The reversed-phase HPLC system was equipped with a Luna C18 column, the mobile system comprised of methanol, water, and dimethylformamide (55:30:15) and the flow rate was set at 0.9 ml/min.
Results: The elution time for nystatin was 4.096±0.025 min. The calibration curves constructed in rat plasma were linear from 0.25 to 50 μg/ml. The lower limit of quantification (LOQ) was found to be 0.25 μg/ml. The standards for accuracy and precision of the intra- and inter-day variation studies were in the acceptable ranges as per the FDA guidelines.
Conclusion: The LOQ value determined by the proposed method was noted to be satisfactory for inspecting the plasma pharmacokinetics of nystatin in rats’ post-administration of a nasal in situ gelling liquid crystalline precursor formulation in an in vivo study.