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DOI: DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.3217.2

Abstract

A simple, rapid, precise and accurate RPHPLC method has been developed and validated for estimation of Imipramine Hydrochloride (IMH) in pharmaceutical dosage form. The method is carried out on Agilent C18 (25 cm x 4.6 mm i. d., 5 ) column with a mobile phase consisting of Methanol: Acetonitrile: Buffer (0.1M Sodium acetate adjusted to pH 4.8 using TEA) in the ratio of 50:30:20 v/v. The flow rate of mobile phase was 1.0 ml/min and the analysis was performed using UVVisible detector at 251 nm. The retention time of IMH was found to be 3.8 min. %RSD of the Imipramine Hydrochloride were and found to be 0.9% and 0.8% respectively. The developed assay method was validated by the guidelines of ICH Q2R1. The method was found to be linear within the range of 20120 µg/ml. The % RSD for intraday precision and interday precision for IMH were found to be 0.58% and 0.16% respectively. The mean recovery of the IMH is 99.83101.04%. The method has been successfully adopted for determination of Imipramine Hydrochloride in pharmaceutical dosage form in regular quality control analysis.

 

Keywords: Imipramine; Validation; Precision; Determination. 

Corresponding Author : A. Lakshmana Rao, Principal, Department of Pharmaceutical Analysis, V.V. Institute of Pharmaceutical Sciences, Gudlavalleru Post, Krishna District, Andhra Pradesh 521356, India.