Why the study?
Carivalan containing carvedilol and ivabradine is widely indicated for patients with stable angina, prompting the creation of precise, eco-friendly, and reproducible spectrophotometric techniques to resolve spectral overlap in their binary mixtures and degradation products.
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Population
Carivalan tablets and laboratory-prepared mixtures of carvedilol and ivabradine
Comparison
Spectrophotometric techniques vs previously reported methods
Design
In vitro analytical and stability-indicating spectrophotometric study
New spectrophotometric methods resolve carvedilol-ivabradine mixtures; leaves open routine quality-control adoption pending validation.
Background Carivalan® dosage form containing carvedilol and ivabradine is widely indicated for patients with stable angina. Three precise, eco-friendly and reproducible spectrophotometric techniques were created for resolving the researched drugs in their mixtures using zero and/or ratio spectra. Technique I is a factorized dual wavelength coupled with spectrum subtraction (FDW-SS), technique II is a ratio difference, and technique III is a constant center coupled with spectrum subtraction (CC-SS). Moreover, CAR and IVA were simultaneously determined in the existence of their oxidative degradation products exploiting the newly developed induced tripartite amplitude difference coupled with ratio subtraction (ITAD-RS) technique. Results The calibration curves for CAR and IVA showed linearity within 3.0–30.0 µg/ml, each. Techniques' precision, accuracy, and linearity ranges were resolved and validated in harmony with ICH guidelines. Additionally, the specificity was examined by examining created combinations of the proposed drugs with LOD of 0.258 and 0.290 for CAR, while for IVA 0.272 and 0.204. Conclusion These techniques were used to determine the presence of the provided drugs in Carivalan® tablets. There is statistical comparison between the found results of the offered spectrophotometric techniques and the previously reported ones with no discernible variance in the acquired results.
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Fiky et al. (2024) studied this question.
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