研究目的
To develop and validate three spectrophotometric methods for the simultaneous determination of Rivaroxaban and Clopidogrel in their binary mixture and tablet dosage forms.
研究成果
The developed methods are accurate, precise, and suitable for simultaneous determination of Rivaroxaban and Clopidogrel in binary mixtures and tablets, with validation confirming reliability for quality control applications.
研究不足
The methods are limited to spectrophotometric analysis and may not detect very low concentrations or complex matrices; optimization for other solvents or real-world samples could be explored.
1:Experimental Design and Method Selection:
Three spectrophotometric methods (first derivative, ratio derivative, and absorbance ratio) were designed to overcome spectral overlap and enable simultaneous quantification. Theoretical models include Beer's law and derivative techniques.
2:Sample Selection and Data Sources:
Pure drugs were purchased, and laboratory-prepared tablets were used. Solutions were prepared in methanol.
3:List of Experimental Equipment and Materials:
Shimadzu UV-Visible double-beam 1601 recording Spectrophotometer (P/N 206-67001) with quartz cuvettes, ultrasonic bath (Model SS 101 H 230), methanol (HPLC grade), and tablet excipients.
4:Experimental Procedures and Operational Workflow:
Standard solutions were prepared, calibration graphs established by measuring derivative amplitudes or absorbances at specific wavelengths, and methods applied to binary mixtures and tablets with sonication and filtration steps.
5:Data Analysis Methods:
Statistical analysis using regression equations, Student's t-test, F-test, and calculations for LOD, LOQ, %RSD, and %Error as per ICH guidelines.
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