Development and validation of liquid chromatogrphic method for Trazodone hydrochloride


Abstract
A simple, isocratic, rapid and sensitive high performance liquid chromatographic method has been developed for quantitative determination of Trazodone Hydrochloride and its three process related impurities. The method has been validated for the determination of related substances in Trazodone Hydrochloride using a C18, ODS (4.6mm×250mm×10μ m) column by keeping the flow rate of 1.5ml / min and having sensitivity of 0.2. The elution is carried out using a mobile phase consisting of methanol l80 ml, Acetonitrile 180 ml, Tetrahydrofuran 40 ml, and Trifluroacetic acid (0.5%) 600 ml. The detection isbeen carried out at 252 nm with injection volume of 10 μ L. The run time is 15 minutes for estimation of related substance. The precision, Linearity and accuracy of the method are demonstrated for Trazodone Hydrochloride. Specificity of the method is also been studied.

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