Determination of toluene residues in diclofenac sodium raw materials by gas chromatography - Master's thesis - Dissertation

A gas chromatography method was developed for the determination of residual toluene in diclofenac sodium raw materials. The analysis was performed using an HP-5 capillary column (0.53 mm × 30 m, 2.65 μm) with nitrogen as the carrier gas and a flame ionization detector (FID). The method employed isothermal conditions with a column temperature of 50°C, an inlet temperature of 200°C, and a detector temperature of 250°C. Toluene was directly injected in split mode, using dimethyl sulfoxide (DMSO) as the solvent and isooctane as the internal standard. The internal standard method was applied to calculate the residual toluene content. The results showed a good linear relationship between 9.27 and 111.19 μg·ml⁻¹ (r = 0.9994), with an average recovery rate of 97.27% (RSD = 2.80%, n = 9). The detection limit (LOD) was 0.59 μg·ml⁻¹, and the limit of quantification (LOQ) was 1.46 μg·ml⁻¹. No excessive toluene residues were found in three different batches of the raw material. This method is accurate, reliable, and suitable for quality control of diclofenac sodium raw materials. It provides a simple and efficient way to monitor residual solvents, ensuring compliance with pharmaceutical standards and improving product safety. The technique can be easily implemented in routine analytical laboratories for consistent and reproducible results.

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