Method Development and Validation For Determining Stability of Omadacycline In Biological Matrices By LC-MS/MS

Satya Prasad B, Jaya Kumari S


The validated protein precipitation method was applied for the estimation of Omadacycline (OM) in human plasma with Omadacycline-D9 (OMD9) as an internal standard (ISTD) by using HPLC-ESI-MS/MS. Zorbax Eclipse Plus C18, 2.1 x 50 mm, 3.5 μm, was selected as the analytical column. The column temperature was set at 45°C. Mobile phase composition was 0.1% formic acid: methanol (80:20 v/v). Source flow rate of 300 μL/min without a split. An injection volume of 10 μL. Omadacycline and Omadacycline-D9 mesylate were eluted at 1.2 ± 0.2 min, with a total run time of 3.0 min for each sample. The mass transitions of Omadacycline and Omadacycline-D9 obtained were m/z 557.6 ® 456.6 and 566.7 ® 456.6, respectively. The standard curve shows a correlation coefficient (r2) greater than 0.9983 with a range of 5.00 to 12000.00 pg/ml using the linear regression model.


Bioanalysis, HPLC-ESI-MS/MS, Human plasma, Omadacycline.

Full Text:




  • There are currently no refbacks.

Copyright (c) 2013 International Journal of Pharmaceutical Quality Assurance

License URL: