RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ALPRAZOLAM AND IMIPRAMINE AS PER ICH GUIDELINES

A rapid and precise Reverse Phase High Performance Liquid Chromatographic method has been developed for the validated of Alprazolam and Imipramine, in its pure form as well as in tablet dosage form. Chromatography was carried out on an Inertsil column, C18(150x4.6 ID) 5µm column using a mixture of Phosphate buffer : ACN (30:70) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 238nm. The Retention Time of the 2.397min for Alprazolam and 3.493 min for Imipramine. The method produce linear responses in the concentration range of 0.5-1.5µg /ml for Alprazolam 50-150µg /ml for Imipramine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations. Keywords: Imipramine; Alprazolam, Method validation ICH guidelines.