Determination of tramadol in pharmaceutical preparations by GC-MS method

In this study, a gas chromatography-mass spectrometry (GC-MS) method was developed to analyze tramadol in both pure form and pharmaceutical formulations. Diclofenac served as the internal standard. The linearity of the GC-MS method was validated within a concentration range of 0.05-5.0 μg mL-1. The intra- and inter-day relative standard deviations were found to be below 1.18% and 3.51%, respectively. The detection and quantification limits for the GC-MS method were determined to be 0.015 and 0.045 μg mL-1, respectively. Stability testing revealed that tramadol remained stable in solutions after 24 hours of incubation at room temperature or after 72 hours of storage at 4 °C and -20°C. Under the selected assay conditions, tablet excipients did not cause anyinterference. Furthermore, the method proved to be effective in quantifying tramadol and ensuring the consistency of formulation content in commercial tramadol dosage forms.