Development of thin layer chromatographic densitometric method for simultaneous quantification of Ivabradine HCl and Bisoprolol fumarate

Abstract

AbstractThe literature review reveals that no thin‐layer chromatographic method has been developed for the simultaneous estimation of Bisoprolol fumarate and Ivabradine HCl in the combined dosage form. A sensitive, precise, accurate, and robust thin‐layer chromatographic method was developed and validated for the simultaneous quantification of a newer combination of Bisoprolol fumarate and Ivabradine HCl used in the treatment of angina, according to the International Council for Harmonization Q2 (R1) guideline. The stationary phase was pre‐coated silica gel aluminum plate 60 F254 and toluene‒methanol‐triethylamine (9:1:0.1, v/v/v) was used as the mobile phase. A common detection wavelength of 279 nm was selected for the simultaneous quantification of Bisoprolol fumarate and Ivabradine HCl. The method was validated for different parameters like linearity, precision, accuracy, robustness, the limit of detection, and the limit of quantification as per the International Council for Harmonization guidelines. The correlation coefficients (r2) for Bisoprolol fumarate and Ivabradine HCl were found to be 0.9976 and 0.9965, respectively. The mean percentage recoveries for Bisoprolol fumarate and Ivabradine HCl were found to be 99.19%–101.70% and 98.71%–101.86%, respectively. As per the International Council for Harmonization Q2 (R1) guideline, the proposed TLC method was repeatable and selective as per statistical analysis and it can be used for simultaneous estimation of Bisoprolol fumarate and Ivabradine HCl in bulk and formulation.