A novel analytical method for the simultaneous determination of three anti depressive disorder drugs by RP-HPLC

Abstract

Although many methods were proposed for the estimation of Fluoxetine Hcl, Alprazolam, and Olanzapine individually or in their dual combinations, no method was proposed for simultaneous estimation of three drugs. This method serves ideal for the estimation three drugs simultaneously in bulk and can be used to estimate any dual combination of two drugs which are formulated. Instrument used for analysis was RP-HPLC, Agilent technologies, 1260 infinity with PDA detector. The detection was done at 227nm with a flow rate of 0.9ml. The mobile phase consists of Acetonitrile and phosphate buffer in the ratio of 70:30 and the pH was adjusted to 6. Phenomenex C18 column (4.6 × 250 mm, 5µ) was used as stationary phase. System suitable parameters were in limits and this method was specific and precise. Retention times were 4.02, 4.37, 5.61 for Fluoxetine Hcl, Alprazolam, and Olanzapine respectively. Resolution between them is more than 2 and signal to noise ratio above 10. The results were accurate and robust. This method was validated according to ICH guidelines.

Keywords: Fluoxetine HCL, Olanzapine, Alprazolam, PDA detector, RP-HPLC, ICH.