Abstract :
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.
Keyword :
Imipramine; Alprazolam, Method validation ICH guidelines.