Development and Validation of New Analytical LC-MS/MS Method for the Estimation of Antidiabetic Drugs Ertugliflozin and Sitagliptin in Combined Pharmaceutical Dosage form

Abstract

Ertugliflozin and Sitagliptin is combination of Antidiabetic drug in tablet Steglujan 15 mg/100 mg film-coated tablets®, a member Antidiabetic drug, is a recent drug developed by Merck Sharp and Dohme Company for the treatment of Type 2 diabetes. Ertugliflozin and Sitagliptin can be used alone or in combination therapy. A highly sensitive, precise and accurate Liquid Chromatography with mass spectrometry (LC-MS/MS) method is developed and validated for the determination of Ertugliflozin and Sitagliptin in combined formulation. Chromatographic separation was carried out on Phenomenex Gemini, C18, (150 × 4.6 mm,5 μm) column. Isocratic method was based on 0.1% formic acid: acetonitrile (10:90, v/vas mobile phase, column temperature at 40°C and flow rate at 0.6 mL/minuteswere utilized. The mass spectrometer was operated under multiple reactions monitoring (MRM) mode using electrospray ionization by monitoring the transition pair (precursor to product ion) of m/z 437.10-328.95in the positive mode for Ertugliflozin and transition pair (precursor to product ion) of m/z 408.10-234.95 in the positive mode for Sitagliptin. The method was found linear in the concentration range of 15 to 450 ng/mL and 100–3000 ng/mL for Ertugliflozin and Sitagliptin respectively. The optimized method was validated according to the International Conference on Harmonization (ICH) and FDA guidelines. The developed method was found suitable for the quantitation of Ertugliflozin and Sitagliptin in Pharmaceutical dosage form.