Terbinafine HCl (TFH) is a synthetic antifungal agent used to treat various types of fungal infections. It is estimated in a tablet dosage form using an eco-friendly, gas chromatographic technique with a flame ionization detector. The drug has shown volatile characteristics at its melting point in the range of 204°C208°C. The TFH was separated in Zebron DB drug column. The study was carried out based on the temperature program by raising the temperature from 230°C to 240°C with a ramp rate of 5°C/minutes and retained for 2 minutes, followed by a raised column temperature to 250°C with a ramp rate of 3°C/minutes which attained a total run time of 10.33 minutes. The drug was eluted with a retention time of 8.5 minutes. The linearity of the method was recorded in the range of 1060 µg/ ml. The results of LOD and LOQ were found to be 0.88 µg/ml and 2.69 µg/ml for TFH, respectively. The method was validated according to the ICH guidelines and values have been found to be in good accordance with the range prescribed. Further stability studies were carried out to evaluate the TFH in tablet dosage forms in the presence of its degradation materials. This new green gas chromatographic method is an easy, rapid, and environmental-friendly way for quantification of TFH in the pure and pharmaceutical dosage form.
Key words: Gas chromatography, Flame ionisation detector, ICH guidelines, Terbinafine HCl, Estimation
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