Application of Validated UPLC/Q-TOF-MS Method for Simultaneous Determination of Telmisartan, Hydrochlorothiazide and their Degradation Products in Tablets

In the presented work the ultra-performance liquid chromatography/quadrupole time-of-flight mass spectrometric (UPLC/Q-TOF-MS) method is developed for simultaneous determination of telmisartan, hydrochlorothiazide and their degradation products in tablets. For identification of drugs, the Q-TOF mass spectrometer was operated in negative ionization mode and quantification was done using the MS/MS transitions at m/z 513.18 to 469.13 for telmisartan, and 268.90 to 204.94 for hydrochlorothiazide. For quantification, the chromatographic separation was achieved on Acquity UPLC^TM BEH C₁₈ (100.0 × 2.1 mm, 1.7μm) column using isocratic mobile phase consisting of acetonitrile-2mM ammonium acetate (50: 50, v/v) at a flow rate of 0.25 mL/min. The elution of telmisartan and hydrochlorothiazide was occurred at 2.25 and 1.22 min, respectively. The calibration curves were linear over the concentration range of 1–1000 ng/mL for both the drugs. The developed method was validated according to ICH guidelines.