Development and Validation of a Stability-indicating RP-HPLC Method Using Quality by Design for Estimating Captopril
Open Access
- 1 January 2019
- journal article
- research article
- Published by OMICS Publishing Group in Indian Journal of Pharmaceutical Sciences
- Vol. 81 (1), 45-56
- https://doi.org/10.4172/pharmaceutical-sciences.1000478
Abstract
The applicability of a quality by design framework for the development of a sensitive, simple and selective, stability-indicating reversed-phase high-performance liquid chromatography analytical method for the analysis of captopril was investigated. Design of experiments using a central composite design approach was used for method development. Twenty experimental runs were performed with acetonitrile content ranging between 28 and 36 % v/v, pH from 2.8 to 3.6 and temperature between 22° and 32°. The experimental data obtained was used to derive a quadratic model for the retention time of captopril. The optimized method produced sharp peaks with good resolution (>2) for captopril and the internal standard with retention times of 3.1 and 6.2 min, respectively. The experimental data revealed that acetonitrile content in the mobile phase and pH are significant factors that affect the retention time and resolution of captopril. Normal probability plots revealed that the residual and predicted data fall approximately on a straight line, indicating that the experimental error for these studies was evenly distributed suggesting that the model could be used to navigate the design space. This approach is useful to expedite method development and optimization activities in analytical laboratories.Keywords
This publication has 16 references indexed in Scilit:
- Expanding the term “Design Space” in high performance liquid chromatography (I)Journal of Pharmaceutical and Biomedical Analysis, 2011
- Optimization and validation of a HPLC method for simultaneous determination of aflatoxin B1, B2, G1, G2, ochratoxin A and zearalenone using an experimental designFood Additives & Contaminants: Part A, 2011
- Development of Quality-By-Design Analytical MethodsJournal of Pharmaceutical Sciences, 2011
- The use of experimental design in the development of an HPLC–ECD method for the analysis of captoprilTalanta, 2011
- Application of response surface methodology to formulation of ionotropically gelled gum cordia/gellan beadsCarbohydrate Polymers, 2010
- Quality-By-Design (QbD): An Integrated Approach for Evaluation of Powder Blending Process Kinetics and Determination of Powder Blending End-pointJournal of Pharmaceutical Sciences, 2009
- Development and Validation of Stability Indicating LC Method to Quantify Captopril in Tablets of Controlled ReleaseChromatographia, 2009
- Response surface methodology (RSM) as a tool for optimization in analytical chemistryTalanta, 2008
- Simultaneous determination of captopril and hydrochlorothiazide in human plasma by reverse-phase HPLC from linear gradient elutionJournal of Pharmaceutical and Biomedical Analysis, 2006
- Validation of the RP?HPLC method for analysis of hydrochlorothiazide and captopril in tabletsAccreditation and Quality Assurance, 2004