Method Development and Validation of Residual Solvents in Paroxetine by Gas Chromatography

The objective of this work is to develop and validate a new gas chromatographic method for the simultaneous determination of acetone and isopropyl alcohol in Paroxetine. To determine the presence of acetone and isopropyl alcohol in paroxetine, a straightforward, accurate, and sensitive gas chromatographic method was created and validated. Using a flame ionisation detector (FID) and gradient column, residual solvents were separated on ZB-1, 30 m length 0.53 mm ID, and film thickness 5 m. The injection was carried out in split mode, with a split ratio of 10:1. Dimethyl acetamide was selected as a diluent to obtain good sensitivity along with the recovery. 1-Propanol was used as an internal standard which employed for area ratio method.

The developed gas chromatographic method offers symmetric peak shape, good resolution of 2.3 min and reasonable retention time for the solvents acetone 9.21 min and isopropyl alcohol 9.845 min. The limit of detection for acetone and isopropyl alcohol was 26.72 µg/ml and 82.96 µg/ml, respectively. Limit of quantitation for acetone and isopropyl alcohol was 80.96 µg/ml and 251.39 µg/ml, respectively. Precision was 0.83 and 0.63. Linearity was y = 0.0004x, R2 = 0.9988 for acetone, and y = 0.0001x+0.0021, R2 = 0.9987 for isopropyl alcohol, and accuracy along with robustness is performed and acceptable results were obtained. Hence, The proposed, developed method was demonstrated as simple, sensitive, linearity, accurate, and robust, So, this method can be used to determine the residual organic solvents in Paroxetine drug substance and drug product. The study concluded that it can be used for the determination of residual solvents in Paroxetine API and also in the finished dosage forms where the particular solvents used for the coating purpose in the pharmaceutical companies and research laboratories.