Rapid And Trace Level Determination Of Potential Genotoxic Imputity 2-Aminopyridine In Piroxicam Api Using Lc-Ms/Ms Technique

Abstract

A highly sensitive method for the determination of genotoxic impurity 2-aminopyridine in Piroxicam employing
hyphenated techniques have been presented. 2-aminopyridine was determined by LC-MS/MS method in
selected ion monitoring mode (SIM) using LiChrospher RP-18 (100×4.6mm) 5.0 µm column. Gradient technique
was applied for the elution of analytes using acetonitrile (mobile phase A) and 0.01M ammonium acetate
buffer (mobile phase B) in different ratios. The gradient program (T/%B) was set as 0/5,2.50/15, 5.00/30,
10.00/50, 15.00/95, 20.00/95. Developed method was validated as per International Conference on
Harmonization guidelines. The LOD and LOQ values found for 2-aminopyridine were 5.25 ppm and 75 ppm.
Method has accuracy within 97 -103.4% for the analyte. This method is a good quality control tool for
quantitation of 2-aminopyridine impurity at very low levels in Piroxicam.