RESUMO
Neuromuscular blocker agent namely; Vecuronium bromide (VEC) was quantified through developing a simple reversed phase liquid chromatographic (RP-LC) method, in drug substance and in drug product. The proposed method could quantify VEC in the presence of its degradation products produced from exposing VEC to different stress conditions as recommended by the International Conference on harmonization (ICH) guidelines. Acidic (2M HCl), basic (2MNaOH) hydrolysis, oxidation (3% H2O2), photolysis (UV light at 254nm), and thermal (135 °C) degradation were estimated by exposing the drug substances to different stress conditions. The separation of the drug from its degradation products was successfully conducted on Tracer Extrasil CN (150 × 4.6mm; 5µm) column using O-phosphoric acid (pH6; 0.05M)-acetonitrile (50:50v/v) as mobile phase. The detection and quantification was done with UV detection at210nm.The validation data were found to be acceptable over a concentration range10-120 µg/ml. The limit of quantification (LOQ) and detection (LOD) were 8.10 and 2.67 µg/ml, respectively. The proposed method met all criteria for validation in accordance with the International Conference on harmonization (ICH) guidelines. The presented work monitored the degradation profile for VEC under various stress conditions and provided a simple LC method for its routine analysis. The structures of the forced degradation products had been described in details using the MS data and the possible degradation pathways were outlined. Besides, the results obtained from the developed method compared statistically with that of the official method indicting high accuracy and precision.
