DEVELOPMENT AND VALIDATION OF THE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR THE QUANTITATIVE DETERMINATION OF
Purpose:
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.
Materials And 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.
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