Ultraperformance liquid chromatography-mass spectrometric method for determination of ampicillin and characterization of its forced degradation products

Abstract

In the current study, a rapid and sensitive UPLC-MS method has been developed for the quantitative analysis of ampicillin in pure and pharmaceutical formulations. Forced degradation analysis was performed and the stress degradation product thus obtained was characterized by mass spectrometry. The chromatographic separation was carried out using BEH C18 column (100 × 2.1 mm, 1.7 μm particle size) using a binary mobile phase mixture of 0.001% acetic acid in water and methanol (30:70). The flow rate was set at 0.3 mL min-1. The total chromatographic analysis time for ampicillin was as short as 1.5 min. The detection and quantitation of the studied drug was carried out using positive electrospray ionization and selected ion reaction modes. The developed method was found to be linear over the concentration range of 0.25-3.0 μg mL-1. The recovery studies suggest an excellent recovery of the procedure which was found in the range of 99.45-100.90%. The relative standard deviation range of the developed analytical procedure ranged from 1.98 to 2.67% in intraday studies and 2.38-2.98% in case of interday study. The limit of detection and limit of quantitation of the method were found to be 0.016 and 0.049 μg mL-1, respectively.