PMID: 26793866Jan 23, 2016Paper

DEVELOPMENT AND VALIDATION OF THE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE QUANTITATIVE DETERMINATION OF ERYTHROMYCIN IN DERMO-PREPARATIONS

Revista medico-chirurgicală̆ a Societă̆ţ̜ii de Medici ş̧i Naturaliş̧ti din Iaş̧i
Manuela HortolomeiCristina Mihaela Ghiciuc

Abstract

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. 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. 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%. The HPLC method with UV detection for the quantitative determination of ER is manageable, responsive, linear, precise and accurate and it can be use...Continue Reading

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