Determination of Ibuprofen using Derivatization with MSTFA in Pharmaceutical Preparations by GC-MS Method

Objective: The aim of this study was to develop and validate a gas chromatography-mass spectrometry (GC-MS) method for the analysis of ibuprofen in both its pure form and pharmaceutical formulations. Methods: A GC-MS method was developed and validated to determine the concentration of ibuprofen. The method's linearity was assessed over a concentration range of 0.5-10 µg mL-1. The intra- and inter-day precision was evaluated, with relative standard deviations calculated. Detection and quantification limits were determined. Stability tests were conducted to assess the stability of ibuprofen solutions at different temperatures. The potential interference of tablet excipients was also evaluated. Results: The GC-MS method demonstrated linearity in the range of 0.5-10 µg mL-1. The intra- and inter-day relative standard deviations were below 1.17% and 3.71%, respectively. The detection limit was 0.15 µg mL-1, and the quantification limit was 0.45 µg mL-1. Stability tests showed that ibuprofen remained stable in solution for 24 hours at room temperature, and up to 72 hours when stored at both 4 °C and -20 °C. No interference from tablet excipients was observed. Conclusion: The GC-MS method is effective for quantifying ibuprofen in both pure form and pharmaceutical formulations. The method provides reliable results with good precision, stability, and no interference from excipients, making it suitable for ensuring the consistency of formulation content in commercial ibuprofen dosage forms.