| Trazodone hydrochloride is an antidepressant of the serotonin antagonist and reuptake inhibitor (SARI) class. It is a phenyl piperazine compound. Trazodone also has anxiolytic and hypnotic effects. Trazodone hydrochloride is a white powder, which is soluble in water and methanol. Trazodone hydrochloride underwent forced degraded under different stress conditions such as Acidic, Basic, Oxidation, Heat and UV light. This step was followed by developing a stability-indicating liquid chromatography method in which the active ingredient was separated from the potential impurities and degradants, which were obtained under different forced degradation conditions. The separation was achieved on Waters-C18 column (4.6 x 250nm, 5micro). The optimum conditions for separation were obtained using mobile phase consisting of 60% Dibasic potassium phosphate buffer (pH 7.0) and 40% Acetonitrile. The flow rate was controlled at 1.0 ml/min with an injection volume of 15-microL and detection wavelength at 248 nm. Under optimum separation conditions, the developed method was validated in terms of linearity, specificity, solution stability, robustness, accuracy, precision, limit of detection (LOD), and limit of Quantitation (LOQ) using both ICH and FDA guidelines. |
