Analytical Quality by Design approach in development and optimization of HPLC method for assay of angiotensin – converting enzyme inhibitor in tablets
Implementation of analytical quality by design approach is a helpful tool in development of a robust analytical method which is applicable throughout the lifecycle of the product. This model is perfect strategy for analytical method development, in order to reduce outof-trend (OOT) and out-of-speci...
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| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association
2024-12-01
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| Series: | Makedonsko Farmacevtski Bilten |
| Subjects: | |
| Online Access: | https://bulletin.mfd.org.mk/volumes/Volume%2069_1/69_1_003.pdf |
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| Summary: | Implementation of analytical quality by design approach is a helpful tool in development of a robust analytical method which is
applicable throughout the lifecycle of the product. This model is perfect strategy for analytical method development, in order to reduce outof-trend (OOT) and out-of-specification (OOS) results and to achieve high degree of robustness, providing cost-effective analytical method.
The aim of this study was to implement a software which uses experimental design plans as an efficient and fast tool for development of
method for quantitative determination of content of ACE inhibitor in tablets. Using statistical models in method development and
optimization, the effect of each factor on responses of interest were calculated and the data were used to find the optimal chromatographic
conditions. Best chromatographic separation within run time of 13 minutes was achieved on column Zorbax SB C18, 150 x 4.6 mm, (5
µm), using a mixture of 15 mM phosphate buffer pH 1.8 and acetonitrile as a mobile phase, with gradient elution and column temperature
maintained at 60 °С. The validated method is specific, linear, accurate, precise and robust for the determination of angiotensin - converting
enzyme inhibitor in tablets. |
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| ISSN: | 1857-8969 |