Evaluation of Aspirin and Dipyridamole Using Low Concentration Potassium Fluoride as a Stabilizer in Human Plasma by LC-MS/MS Mode

The objective of this work is to develop a stable, specific, accurate and precise bioanalytical method for the determination of aspirin and dipyridamole in human plasma using LC-ESI-MS/MS. Sample extraction is carried out using solid phase extraction technique. Methanol: 0.10 % formic acid in water (90:10 v/v) is used as a mobile phase and separation was achieved in 3 min on a Chromolith® high resolution, 100 × 4.6 mm, 5 μ analytical column. Detection is performed using MRM transitions 178.9/136.8 with positive polarity for aspirin and 525.7/505.6 with negative polarity for dipyridamole on a API 4000 mass spectrometer. This method is specific and calibration range is found linear over the range 5.073 to 802.820 ng/mL for aspirin and 50.051 to 4004.069 ng/mL for dipyridamole. Method is validated as per EMA and USFDA guidance on bioanalytical method. Method is successfully applied to conduct bioequivalence studies.