Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF IMIPRAMINE AND ALPRAZOLAM IN PHARMACEUTICAL DOSAGE FORMS

P.Gayathri*, KN Jayaveera, Sasikirangoud, N.Sravan Reddy

ABSTRACT

The aim of the present study is to develop a new, simple, rapid, accurate and precise RP-HPLC method for the simultaneous estimation of Imipramine (Imi) and Alprazolam (Alp) in bulk and in tablet formulations. The chromatographic separation was done by waters with BDS, 250*4.6mm, 5μ column and is maintained at 30oC temperature with mobile phase of Buffer: Acetonitrile [50:50 v/v], flow rate 1ml/min, injection volume 10μl and runtime maintained is of 8min. Buffer was prepared by weighing 2.72gm of potassium dihydrogen ortho phosphate in a 1000ml volumetric flask and add 900ml of milli-Q water and sonicated for 10min to degas and finally make up the volume with water then added 1ml of triethyl amine then pH adjusted to 3.3 with dil. ortho phosphoric acid. The retention time and mean recoveries for Imi was obtained at 2.957and 99.90 %, Alp was at 4.446and 99.91%. Linearity response was established over the concentration range of 50-300ppm for Imi and 0.5-3ppm for Alp. The correlation coefficient for Imi and Alp was 0.9999and 0.9975 respectively. The correct information about the recovery studies was found by the accuracy of the proposed method and the results were validated as per ICH guidelines. This method can be used for the routine quality control of both drugs in combination in bulk and tablet dosage forms.

Keywords: Imipramine, alprazolam, RP-HPLC and validation