Quantification of Sarecycline in Rat Plasma Using a Sensitive LC-MS/MS Method for Preclinical Study

Purpose The main view of the present research is to develop a simple, selective and sensitive method to quantify Sarecycline by LC-MS/MS method in rat plasma, using doxycycline as internal standard and to apply the validated method for pre clinical study.MaterialsChromatographic separation was achieved on Waters symmetry C18 column (50 x 4.6 mm, 3.5 mu m) using water of 0.05% formic acid and acetonitrile as mobile phase in gradient mode. Mass detection was achieved by ESI/MS/MS positive ion mode, monitored for sarecycline and doxycycline at m/z488.4 & RARR; 302.4, 444.8 & RARR; 243.7 respectively.Results The linear scope of the calibration curve was observed to be ranging between 1 and 2028 ng/mL with a coefficient of correlation 0.999 and the lower limit of quantification at 1 ng/mL. Both the precision (RSD, %) and accuracy (RE, %) were found to be within the limits and matrix effect was observed negligible. Sarecycline was found to be stable throughout the freeze thaw cycles, bench top studies and autosampler studies. The validated method was further applied to quantify Sarecycline as part of pharmacokinetic studies after oral treatment with 1 mg/kg sarecycline to rats.Conclusion The developed method exhibited linearity, sensitivity, accuracy and precision with minimal matrix interference and its application to pharmacokinetic profile could assist advanced investigational and pharmacokinetic studies of sarecycline. [GRAPHICS] .