Abstract

DEVLPOMENT AND VALIDATION OF RP-HPLC METHODS FOR SIMULTAINOUS ESTIMATION OF IMIPRAMINE HCL AND DIAZEPAM IN BULK AND PHARMACEUTICAL FORMULATIONS

Nena S. Jaiswal*, Nidhi P. Kadam, Krupali K. Prajapati, Het S. Patel, Yash D. Dabgar, Prof. Mitali Dalwadi, Dr. Chainesh Shah and Dr. Umesh Upadhyay

Abstract

A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic method was developed for the simultaneous determination of Diazepam and Imipramine hydrochloride, using a ODS C-18 (250 x 4.6mm, 5μm) column at temperature 300C and flow rate 1mL/min. A mobile phase compried of Methanol: water (Phosphate buffer (75:25 v/v, pH 6.6 with potassium hydroxide). The retention times of Diazepam and Imipramine hydrochloride were found to be 2.85 min and 5.24 min, respectively. Linearity was established for Diazepam and Imipramine hydrochloride in the range of 10-500 μg/ml and 2-12 μg/ml, respectively. The recovery was in the range of 97.67 – 99.59% for Imipramine hydrochloride (IMI) and 97.39 – 99.52% for diazepam (DIA), respectively. Both the drugs were subjected to variance of conditions like flow rate, difference in mobile phase and concluded that this method can be successfully employed for simultaneous quantitative analysis of Diazepam and Imipramine hydrochloride in bulk drugs and formulations.

Keywords: Imipramine HCL, Diazepam hydrochloride, HPLC, Bulk drugs, Pharmaceutical formulations.