Optimization and Validation of an HPLC Method for the Analysis of Carvedilol and Impurities

In this study, a liquid chromatography method was developed and validated for the accurate determination of carvedilol content while minimizing interference from impurity C and N-formyl carvedilol and allowing precise impurity analysis. The reliability of the method was verified through key parameters such as linearity, precision, accuracy, and stability, ensuring robust performance in the detection and quantification of carvedilol and related impurities. And, the method was tested under varying conditions, including changes in the flow rate, initial column temperature, and mobile phase pH. The results showed that the method demonstrated excellent linearity, with R ² values consistently above 0.999 for all analytes. Precision tests yielded RSD% values below 2.0%, confirming the method's repeatability. Accuracy assessments revealed recovery rates ranging from 96.5% to 101%, while stability studies indicated minimal variation in peak areas and impurity content over extended time periods. These results confirm the method's reliability for accurate quantification and impurity analysis in pharmaceutical samples.