DEVELOPMENT AND OPTIMIZATION OF AN ECONOMIC METHOD FOR QUANTITATION OF AZITHROMYCIN IN HUMAN PLASMA BY TANDEM MASS SPECTROSCOPY (LCMS/MS) FOR CLINICAL TRIALS
Journal Title: Pharma Science Monitor-An International Journal Pharmaceutical Sciences - Year 2010, Vol 1, Issue 2
Abstract
The present study deals with development and optimization of an economic method for quantitation of Azithromycin in human plasma by Tandem Mass Spectroscopy (LCMS/MS) for Clinical studies. Enalapril (stable and economic) was used as an internal standard. Azithromycin was extracted from plasma using an Oasis HLB solid-phase extraction cartridge (Waters Corporation, USA). The elution was carried out with degassed 0.1% formic acid buffer in methanol (5:95, v/v, economic as compare to commonly used acetonitrile). After elution the elute was evaporated to dryness in nitrogen, and was reconstituted in 100 μl mobile phase (same as elution buffer) and 10 μl of the sample was injected into an HPLC system containing Chromolith RP C18, 100*4.6 mm column connected to LCMS/MS system. The lower limit of quantitation (LLOQ) was 0.95ng/ml, without interfering peaks. The calibration curve was linear (R=0.9979) over a concentration range 0.95ng/ml to 951.63 ng/ml. Retention time for Azithromycin and its internal standard was 1.26 minutes and 1.45 minutes. The accuracy (85%-115%) and precision (CV ≤ 15%) were acceptable. The mean recoveries for Azithromycin at 3, 425 and 875 ng/ml were: 75.44±2.86%, 79.23±4.475% and 74.84±2.86% (n=6), respectively. Azithromycin was stable in plasma for at least 6 hours at room temperature and for at least four freeze and thaw cycles (% change = 3.73 at LOQ and 4.46 at ULQ). It was observed that the method is selective for Azithromycin as no peak interference was observed from plasma matrix while blank plasma or plasma with the drugs was run at RT of internal standard and analyte. The developed method has adequate sensitivity, specificity, accuracy and precision to measure Azithromycin in human plasma and, it can be considered as a cost effective, fast and with the acceptable range of recovery (80% - 90%) for BE studies/clinical trials.
Authors and Affiliations
Snehal Shah* , Rachana
Keywords
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