Isolation and characterization of impurities in docetaxel

Nano-Sized Assemblies of a PEG-Docetaxel Conjugate as a Formulation Strategy for Docetaxel

“…The DTX composition in the conjugate was measured by 1 H NMR analysis and found to be 26% (wt%). The characteristic resonances for DTX, have been observed in the 1 H NMR spectrum for PEG–DTX, confirming the successful synthesis of the conjugate 35. Importantly, in the spectrum for the PEG–DTX conjugate, the disappearance of the resonance at δ = 4.62 ppm (br, s, 1H) which is observed in the spectrum for DTX and corresponds to the proton of the 2′ carbon confirms the completion of the conjugation reaction at this position.…”

Isolation and characterization of degradation impurities in docetaxel drug substance and its formulation

“…These impurities were isolated using preparative LC and characterized by using NMR and LC-MS/MS spectral data. The degradation impurity, 10-deacetyl baccatin III and 7-epi docetaxel were known previously [6], while other three degradation impurities were found to be previously unreported. The monitoring of these impurities is important for pharmaceutical drug development and quality control of drug substance and its formulation.…”

Enhancement of the Solubility and Efficacy of Poorly Water-Soluble Drugs by Hydrophobically-Modified Polysaccharide Derivatives

“…The excess drug that could not be dissolved in the polymer solutions was removed by centrifugation (20,000Âg, 30 min). The amount of drug solubilized in the polymer solutions was determined by UV spectroscopy for benzophenone (l=259 nm) and by HPLC for docetaxel (29,30). For HPLC measurements, the samples were first diluted 280 fold in an acetonitrile-water (60:40) mixture, then 50 mL of the diluted sample were injected into a Nucleosil C18, 5 mm column (Merck) equipped with a C18 column guard.…”