Dual Analyte Determination and Validation of Trace Levels MethanesulfonicAcid and Trifluroacetic Acid in Saxagliptin Drug Substance using IonChromatographic Technique

A sensitive ion chromatgraphic method was developed and optimized for the determination of methanesulfonic acid and trifluroacetic acid in saxagliptin drug substance. These organic acids in lower limits act as potential impurities and causes undesirable by products. The method was developed to enhance the detection by this technique and minimizing the acquisition time by using 30 min. To prove the performance characteristic of the optimized method validation parameters performed as per the ICH guidelines requirements for selectivity, sensitivity, LOD, LOQ, linearity, precision, robustness and accuracy.