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A sensitive LC-MS/MS method has been developed and validated for the quantitative determination of Dexlansoprazole from the commercially available formulations. Omeprazole was used as the internal standard. Isocratic separation was achieved using Zorbax SB C 18 column (4.6 × 100 mm, 3 µm) as a stationary phase and the mobile phase consists of (0.5 mM) Ammonium Acetate adjusted to pH 3.5: acetonitrile (30:70 V/V) with a flow of 0.5 mL/min. Detection was carried out by triple quadrupole mass spectrometry with electrospray ionization in positive mode with proton adducts at m/z 370.05 to 251.95 and 346.00 to 198.05 to monitor Dexlansoprazole and Omeprazole. The linearity of the method was found over a concentration range of 0.5-3000 ng/mL with a regression analysis of 0.9994. The percentage recovery of the present method was found to be 94.33 to 99.97%. The LC-MS/MS method was validated as per ICH guidelines. The developed method can be successfully applied for the estimation of Dexlansoprazole in the commercial formulation and in bulk drug.

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