To develop a simple, precise and accurate LC-MS/MS method for the estimation of dexlansoprazole in spiked human plasma with cost effective protein precipitation extraction technique. The validation of the proposed method was done according to the ICH and FDA guidelines. Omeprazole was used as the internal standard (IS). The method was developed in isocratic separation mode using Zorbax SB C18 column (4.6 x 150 mm, 3µm) as a stationary phase and the mobile phase consists of 0.5 mM Ammonium acetate buffer, adjusting the pH to 3.5 using glacial acetic acid and acetonitrile in the ratio of 30:70% V/V with a flow of 0.5 mL/min. Detection in UV was at 284 nm and it was carried out by triple quadrupole mass spectrometry with electrospray ionization in positive mode. Proton adducts at m/z 369.95 > 251.95 and 346.00 > 198.05 to monitor Dexlansoprazole and Omeprazole. The method was found to be linear 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 99.54 ± 0.28%. The method was found to be stable. The developed LC-MS/MS method will be suitable for the analysis of dexlansoprazole and applied for routine analysis in different quality control and research laboratories. It will be more precise, accurate and cost effective while comparing to the reported method.
Index Terms- Dexlansoprazole, Omeprazole, Human Plasma, LC-MS/MS, Validation, FDA, Electrospray Ionization