A new validated bio-analytical liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method for the quantification of Azithromycin in human plasma

Abstract

A simple, rapid and sensitive LC-MS/MS method was developed and validated for the quantification of azithromycin (AZI) in human plasma. Sildenafil citrate was used as an internal standard. The analytes were extracted from human plasma samples by liquid-liquid extraction technique. The reconstituted samples were chromatographed on a reversed ‑ phase column C18, 50 × 2.1 mm, 5 µm from Waters, by using a 80:20 (v:v) mixture of acetonitrile and 0.1% formic acid in water as the mobile phase at a flow rate of 0.5 mL/min. The calibration curve was linear (r² > 0.99) over the concentration range of 5.0-1500.0 ng/mL. The results of the intra- and inter-day precision and accuracy studies were within the acceptable limits. A run time of 0.5 min for each sample made it possible to analyze more than 400 plasma samples per day.