title: DEVELOPMENT AND VALIDATION OF THE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE QUANTITATIVE DETERMINATION OF ERYTHROMYCIN IN DERMO-PREPARATIONS.
abstract: OBJECTIVE
  For the analysis of erythromycin (ER) in topical pharmaceutical forms we developed a high performance liquid chromatography dosage method (HPLC) greatly improved over the method formalized by the European Pharmacopoeia 5th ed.
  
  
  METHODS
  The work conditions for using a chromatography column with C18 stationary phase were established as follows: optimal column temperature, 45 degrees C; the mobile phase consisted of a mixture of 0.001 M disodium phosphate solution : acetonitrile in the ratio 20:80, volume of sample injected 20 μL, injection rate 1 mL/min and spectrum was recorded at λ = 200 nm. The method was validated by determining the following parameters: system precision, linearity, limit of detection (LOD), limit of quantification (LOQ) and accuracy.
  
  
  RESULTS
  We determined linearity in the concentration range studied, 0.025 to 1.5 mg/mL. The equation of the regression line is: A = 53.7430 x C + 0.00203 with a regression coefficient of 0.9997. The method has LOQ = 0.0196 mg/mL and LOD = 0.005969. The accuracy of the method is appropriate, the ER recovery degree is in the range of 101.27 - 104.99%.
  
  
  CONCLUSIONS
  The HPLC method with UV detection for the quantitative determination of ER is manageable, responsive, linear, precise and accurate and it can be used for the quantitative analysis of ER in topical pharmaceutical formulations. UV DETECTION.
authors.forename: Manuela
authors.initials: M
authors.lastname: Hortolomei
authors.forename: Lacramioara
authors.initials: L
authors.lastname: Ochiuz
authors.forename: Iuliana
authors.initials: I
authors.lastname: Popovici
authors.forename: D
authors.initials: D
authors.lastname: Timofte
authors.forename: Diana Cezarina
authors.initials: DC
authors.lastname: Petrescu
authors.forename: Cristina Mihaela
authors.initials: CM
authors.lastname: Ghiciuc
mesh_terms: D000279:Administration, Cutaneous; D000900:Anti-Bacterial Agents / Q000032:analysis*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D003879:Dermatologic Agents / Q000032:analysis*; D004917:Erythromycin / Q000032:analysis*; D006801:Humans; D015203:Reproducibility of Results
chemical_list: D000900:Anti-Bacterial Agents; D003879:Dermatologic Agents; D004917:Erythromycin