Simultaneous Gas Chromatographic Analysis of Isopropyl Alcohol, t-Butanol, 2-Bromo Propane, Toluene and Acetic Acid in Teneligliptin Drug

Abstract

Teneligliptin (TNN), a true third-generation gliptin, has firmly established itself as an essential therapeutic molecule in the therapy of diabetes. The monitoring of isopropyl alcohol (ISO), t-butanol (BUT), 2-bromo propane (BRO), toluene (TOU) and acetic acid (ACE) in TNN is necessary to maintain TNN’s stability, bioavailability and solubility. We have established a “gas chromatography” approach for ISO, BUT, BRO, TOU and ACE determination in TNN sample. The analysis of ISO, BUT, BRO, TOU and ACE in TNN were performed deploying ZB-624 analysing column. The flame ionizing sensor was deployed. Linear response was ascertained for ISO, BUT, BRO, TOU and ACE over the concentration arrays 29.96 to 7512ppm, 25.83 to 759 ppm, 48.48 to 762ppm, 4.92 to 1362ppm and 222.41 to 7527ppm, respectively. Detection limits were 8.99ppm (ISO), 7.75ppm (BUT), 14.55ppm (BRO), 1.34ppm (TOU) and 67.47ppm (ACE). The “gas chromatography” approach validation set their precision, specificity, accuracy and robustness. Routine monitoring and proper analysis of ISO, BUT, BRO, TOU and ACE in TNN sample in quality management laboratories could be accomplished deploying “gas chromatography” approach.