DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF ROSUVASTATIN AND EZETIMIBE IN BULK AND PHARMACEUTICAL DOSAGE FORM

The present investigation describes the development and validation of a simple, precise, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous determination of rosuvastatin and ezetimibe in bulk drug and pharmaceutical dosage forms. The study aimed to establish a reproducible analytical procedure that ensures accurate quantification of both analytes in combined dosage forms, thereby supporting routine quality control and regulatory compliance. Several mobile phase compositions were evaluated, and the optimized mixture of acetonitrile, methanol, and phosphate buffer (pH 3.0) in the ratio 40:40:20 v/v provided sharp, well-resolved peaks with distinct retention times of 3.912 minutes for rosuvastatin and 5.012 minutes for ezetimibe. The chromatographic conditions ensured reproducibility, minimal tailing, and efficient separation without interference from excipients or mobile phase components. Validation of the method was performed in accordance with ICH Q2(R1) guidelines. Linearity was established over the concentration range of 50–300 μg/mL for both drugs, with correlation coefficients greater than 0.999, confirming excellent linear response. Precision studies demonstrated %RSD values below 2%, indicating high repeatability and reproducibility. Accuracy was verified through recovery experiments, with results consistently falling within the acceptable range of 98–102%. Specificity was confirmed by the absence of interfering peaks at the retention times of the analytes. Robustness testing showed that deliberate variations in flow rate, wavelength, and mobile phase composition did not significantly affect the results. Sensitivity was demonstrated by low limits of detection (LOD) and quantification (LOQ), ensuring applicability for trace analysis. The developed RP-HPLC method is reliable, accurate, and sensitive for the simultaneous estimation of rosuvastatin and ezetimibe. Its simplicity and reproducibility make it suitable for routine quality control analysis in pharmaceutical laboratories. The method not only facilitates efficient monitoring of combined dosage forms but also contributes to ensuring therapeutic efficacy and patient safety. Overall, this validated approach provides a strong analytical tool for regulatory compliance and industrial application.

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