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In Vitro Dissolution Profile of Antihypertensive Mixture: Comparison between Multivariate Methods and Statistical and Graphical Representation of Different Univariate Spectrophotometric Data.

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BACKGROUND Triplixam is a new antihypertensive drug combination consisting of Perindopril, Amlodipine, and Indapamide which have a synergistic mechanism of action in combination with each other. OBJECTIVE Comparative study of… Click to show full abstract

BACKGROUND Triplixam is a new antihypertensive drug combination consisting of Perindopril, Amlodipine, and Indapamide which have a synergistic mechanism of action in combination with each other. OBJECTIVE Comparative study of different spectrophotometric approaches used for the simultaneous determination of Perindopril, Indapamide, and Amlodipine in bulk powder and in dosage form Triplixam. METHODS The methods include univariate and multivariate spectrophotometric methods depending on either mathematically calculation or graphically representation of data. For the univariate methods: Perindopril were resolved from other component using Constant multiplication followed by spectrum subtraction resolution technique then Two Base Point, AUC, Constant value, and Concentration value methods were applied. For both Amlodipine and Indapamide: Constant multiplication resolution technique was used then Constant value and Concentration value methods were applied. Concentration Value depends on graphical representation of data rather than statistical data. PLS and PCR chemometric assisted spectrophotometric techniques were also applied. The proposed methods are considered green alternative to the reported methods as the greenness of the proposed methods was evaluated qualitatively and quantitatively by four green analytical evaluation tools. RESULTS The methods were applied for the analysis of the mixture in the pharmaceutical dosage form Triplixam, and in vitro release at intestinal pH (7.4) using a USP dissolution tester. CONCLUSION The proposed green analytical methods considered to be greener than the reported methods and simpler so could be used as alternative for routine analysis of the mixture in quality control laboratories for the reason of their accurate results beside minimum manipulation steps that reduced the error and time required of the analysis with no harmful effect on analyst health as well as the environment. HIGHLIGHTS The study was the first in vitro dissolution profiling of Perindopril, Amlodipine, and Indapamide. The developed methods were of excellent green methods without compromising the analytical criteria.

Keywords: mixture; vitro dissolution; graphical representation; value; representation

Journal Title: Journal of AOAC International
Year Published: 2022

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