Determination of residual erythromycin antibiotic in lyophilized measles vaccine by liquid chromatography mass spectrometry.

Ngô Ngo1, , Van Ha Nguyen1, Dang Hien Nguyen2, Thuy Huong Nguyen2, Anh Thu Phan2
1 National Institue of Drug Quality Control
2 Centre for Research and Production of Vaccines and Biologicals

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Abstract

A simple and sensitive method was developed for determination of residual erythromycin in lyophilized measles vaccine using liquid chromatography tandem mass spectrometry (LC-MS/MS). Erythromycin was extracted from vaccine with methanol. Liquid chromatography was performed on an Acquity BEH-C18; (100 x 2,1 mm; 1,7 μm) column with gradient program of 0.1 % aqueous solution of formic acid and acetonitrile containing 0.1 % formic acid as mobile phase at flow rate of 0.2 mL per minute, temperature: 400C. The Waters Xevo TQD UPLC-MS/MS was operated under the multiple-reaction monitoring (MRM) mode using the ESI+ mode with transitions at (m/z) 734.5 → 157.9 and 734.5 → 576.4. The method was validated for the specificity, linear range, precision, accuracy, LOD and LOQ. The validation results showed that the method was suitable for determination of residual erythromycin in lyophilized measles vaccine.

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