Stability Indicating Method Development and Validation for the Estimation of Carvedilol and Ivabradine by Rp-HPLC Method

This study deals with the development and validation of a stability-indicating RP-HPLC method for the quantitative estimation of Carvedilol and Ivabradine in bulk and pharmaceutical dosage preparations. Both agents are widely used in the treatment of cardiovascular diseases: Carvedilol is a non-selective beta-adrenergic antagonist with alpha-1 blocking activity, while Ivabradine inhibits selectively the If channel, causing the heart rate to go down. A precise analytical tool has to be developed-providing evidence of its accuracy, precision, specificity, and ruggedness-prior to the further quality control and stability studies. The method development was done by optimizing the chromatographic parameters such as mobile phase composition, flow rate, and detection wavelength to achieve adequate resolution and symmetrical peak morphology. The proposed method was subsequently validated for linearity, precision, accuracy, specificity, limit of detection, limit of quantitation, and robustness according to ICH. The various forced degradation studies - thermal, oxidative, photolytic, acidic, and alkaline - were done in order to evaluate the capability of the method regarding separation between degradation products and analytes to provide stability indicating. The obtained results ensure that the method is appropriate to quantify both drugs in presence of degradation products for the quality control and stability study of pharmaceutical formulations.