Development and Validation of an LC/MS Compatible, Stability indicating RP-UPLC Method for Faropenem

Abstract

In this manuscript an ultrafast, stability-indicating RP-UPLC method with Waters Acquity UPLC having 2996 PDA detection was developed and validated for the quantification of faropenem in the bulk drug and its tablet formulation. The analysis was performed using End version C18 column powered with Software Empower 2 and a mobile phase of 10mM Ammonium formate buffer (pH=3.5): ACN in the ratio of 65: 35(v/v) in isocratic mode at a flow rate of 0.25mL/min at 313nm as the detection wavelength. The linearity range is 5–50μg/mL, and the linear regression analysis of the calibration plot showed a good linear relationship with R2 = 0.9999. The LOD and LOQ were 213 and 638ng/mL, respectively. The stress conditions include acid, alkali, hydrogen peroxide and UV light. The drug peak was well resolved from the degradation products’ peaks, and thereby, the proposed method can be used for the analysis of stability samples.