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RP-HPLC Method Development and Validation for the Estimation of Imipramine Hydrochloride in Pharmaceutical Dosage Form

A. Lakshmana Rao, Principal, Department of Pharmaceutical Analysis, V.V. Institute of Pharmaceutical Sciences, Gudlavalleru Post, Krishna District, Andhra Pradesh 521356, India. , A. Lakshmana Rao* , Prasanthi T.** , Chakradhar J.V.U.S.*** , Mounika G.N.L.*** , Triveni B.*** , Bindu A.H.*** , Devi K.S.***

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Journal of Pharmaceutical and Medicinal Chemistry 3(2):p 67-73, Jul-Dec 2017. | DOI: DOI: http://dx.doi.org/10.21088/jpmc.2395.6615.3217.2

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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. 

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

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