Dual Analyte Determination and Validation of Trace Levels Methanesulfonic Acid and Trifluroacetic Acid in Saxagliptin Drug Substance using Ion Chromatographic 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.

Author(s): Nageswara Rao M, Kishore Babu PN, Hemant Kumar Sharma, K. Joseph Prabahar, G. Himabindu, K. Raghubabu

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