Pharmaceutical analysis of linagliptin and empagliflozin using LC-MS/MS

Abstract

A new LC-MS/MS method was developed for determination of empagliflozin and linagliptin in pharmaceutical pure forms and dosage forms. Regression parameters, LOD, LOQ, accuracy and precision were investigated. Linearity was found to be acceptable over the concentration ranges of 25 - 800 ng mL-1 and 50 - 1600 ng mL-1 for linagliptin (LG) and empagliflozin (EG), respectively. Sb and Sa values of (4.43 * 10-3 - 2.04) and (2.46 * 10-3 - 2.27) were acceptable for LG and EG, respectively. Furthermore, LOD and LOQ were found to be (4.45 ng mL-1 -13.50 ng mL-1) and (11.08 ng mL-1 - 33.57 ng mL-1) for LG and EG, respectively. The results of accuracy and precision calculations including the mean of the recovery and the standard deviation were (99.73 % ± 1.38) and (100.15 % ± 1.15) for LG and EG, respectively. The optimized method was proved to be accurate for the quality control of the investigated drugs either in bulk or in pharmaceutical formulation.