title: Development, Optimization, and Validation of a Green and Stability-Indicating HPLC Method for Determination of Daptomycin in Lyophilized Powder.
abstract: Daptomycin is an antimicrobial that plays an important role in clinical practice today because it is considered a promising drug to combat resistant strains, such as methicilin and vancomycin-resistant Gram-positive bacteria. Considering the analysis of daptomycin in a pharmaceutical dosage form, the only method found in literature uses potentially toxic organic solvents. Therefore, the objective of this work was to develop a green and stability-indicating HPLC method for determination of daptomycin in lyophilized powder. The mobile phase was ethanol-water (55+45, v/v) at pH 4.5 pumped at a flow rate of 0.6 mL/min. A C18 column was used, and UV detection was performed at 221 nm. Stress degradation studies were conducted in order to demonstrate the specificity and stability-indicating capability of the method. The method was validated according to International Conference on Harmonization guidelines, proving to be linear (r=0.9996), precise, accurate, robust (demonstrated by the Plackett-Burman model), and specific within the range 20-70 μg/mL. The retention time of daptomycin was 5.8 min. It can be concluded that the validated method can be a fast, safe, and environmentally friendly alternative for the analysis of daptomycin.
authors.affiliation: Universidade Estadual Paulista, School of Pharmaceutical Sciences, Radovia Araraquara-Jáu, km1, 14801-902, Araraquara, SP, Brazil.
authors.forename: Eliane Gandolpho
authors.initials: EG
authors.lastname: Tótoli
authors.forename: Hérida Regina Nunes
authors.initials: HR
authors.lastname: Salgado
mesh_terms: D000900:Anti-Bacterial Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D017576:Daptomycin / Q000032:analysis*; D004355:Drug Stability; D000431:Ethanol / Q000737:chemistry; D005612:Freeze Drying; D055772:Green Chemistry Technology; D017408:Guidelines as Topic; D006863:Hydrogen-Ion Concentration; D011208:Powders; D015203:Reproducibility of Results; D014867:Water / Q000737:chemistry
chemical_list: D000900:Anti-Bacterial Agents; D011208:Powders; D014867:Water; D000431:Ethanol; D017576:Daptomycin