Rapid and Trace Level Determination of Potential Genotoxic Impurity 2-Aminopyridine in Piroxicam API Using LC-MS/MS Technique

A sensitive genotoxic impurity detection technique Hyphenated 2-aminopyridine in Piroxicam is given. 2- aminopyridine was measured using LiChrospher RP-18 (100×4.6mm) 5.0 µm column in selected ion monitoring mode (SIM) in LC-MS/MS. Analytes were eluted using acetonitrile (mobile phase A) and 0.01M ammonium acetate buffer (mobile phase B) in varied ratios utilizing gradient method. The gradient program (T/%B) was 0/5, 2.50/15, 5.00/30, 10.00/50, 15.00/95, 20.00/95. The validated technique adhered to the guidelines set forth by the International Conference on Harmonization.It was determined that the LOD and LOQ values for 2-aminopyridine were 5.25 ppm and 75 ppm, respectively. For the analyte, the method has an accuracy that ranges from 97 to 103.4%. Quantitation of 2-aminopyridine impurity at extremely low levels in piroxicam may be accomplished with the use of this approach, which is an effective quality control tool.