Optimization of HPLC method using central composite design for estimation of Torsemide and Eplerenone in tablet dosage form

A simple, precise, accurate and robust high performance liquid chromatographic method has been developed for simultaneous estimation of Torsemide and Eplerenone in tablet dosage form. Design of experiment was applied for multivariate optimization of the experimental conditions of RP-HPLC method. A C...

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Bibliographic Details
Authors: Hinge,, Madhuri Ajay, Patel, Dipti
Format: article
Status:Published version
Publication Date:2022
Country:Brasil
Institution:Universidade de São Paulo (USP)
Repository:Brazilian Journal of Pharmaceutical Sciences
Language:English
OAI Identifier:oai:revistas.usp.br:article/205183
Online Access:https://www.revistas.usp.br/bjps/article/view/205183
Access Level:Open access
Keyword:Torsemide
Eplerenone
Quality by Design
RP-HPLC method
Tablet
Description
Summary:A simple, precise, accurate and robust high performance liquid chromatographic method has been developed for simultaneous estimation of Torsemide and Eplerenone in tablet dosage form. Design of experiment was applied for multivariate optimization of the experimental conditions of RP-HPLC method. A Central composite design was used to study the response surface methodology and to analyse in detail the effects of these independent factors on responses. Total eleven experiments along with 3 center points were performed. Two factors were selected to design the matrix, one factor is variation in ratio of Acetonitrile and the second factor is flow rate (mL/min). Optimization in chromatographic conditions was achieved by applying Central composite design. The optimized and predicted data from contour diagram comprised mobile phase (acetonitrile, water and methanol in the ratio of 50: 30: 20 v/v/v respectively), at a flow rate of 1.0 ml/min and at ambient column temperature. Using these optimum conditions baseline separation of both drugs with good resolution and run time of less than 5 minutes were achieved. The optimized assay conditions were validated as per the ICH guidelines (2005). Hence, the results showed that the Quality by design approach could successfully optimize RP-HPLC method for simultaneous estimation of Torsemide and Eplerenone.