Development of an enhanced separation of erythromycin and its related substances by liquid chromatography.
A new HPLC-UV method for the determination of the impurity profile of erythromycin is developed. In contrast to the liquid chromatography described in the European Pharmacopoeia the analysis could be performed at a temperature of 25 degrees C. Erythromycin samples were analysed on an endcapped RP phase with cyanopropyl groups on the surface using gradient elution with 32 mM potassium phosphate buffer pH 8.0 and acetonitrile/methanol (75:25). The aforementioned method shows clear improvements compared to the actual method of the European Pharmacopoeia, which is less selective and sensitive.
Deubel
A
A
Institute of Pharmacy and Food Chemistry, University of Würzburg, Am Hubland, 97074 Würzburg, Germany.
Holzgrabe
U
U
D000900:Anti-Bacterial Agents / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004304:Dosage Forms / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control; D004917:Erythromycin / Q000031:analogs & derivatives / Q000032:analysis*; D017408:Guidelines as Topic; D015394:Molecular Structure; D011786:Quality Control; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet / Q000379:methods*; D013678:Technology, Pharmaceutical / Q000379:methods*; D013696:Temperature
D000900:Anti-Bacterial Agents; D004304:Dosage Forms; D004917:Erythromycin