The developed RP-HPLC method showed linearity with R² >0.999, accuracy with 99.7-100.0% recovery for Simvastatin and 99.85-100.18% for Carvedilol, and assay results of 94.32% and 105.54% respectively in tablet formulations.
A validated RP-HPLC method provides a reliable, accurate, and precise approach for the simultaneous routine quality control analysis of simvastatin and carvedilol in combination tablets.
For the simultaneous measurement of Simvastatin and Carvedilol in tablet dose form, a straightforward, accurate, precise, and reliable reverse phase high-performance liquid chromatographic (RP-HPLC) approach was created and validated. Using a mobile phase made up of 60:40 v/v of Phosphate buffer: Methanol (pH 4.0 adjusted with Orthophosphoric acid) at a flow rate of 1.0 mL/min, chromatographic separation was accomplished on a C18 column (250 × 4.6 mm, 5 μm). At 245 nm, detection was done. Simvastatin and Carvedilol were shown to have retention durations of 2.57 and 5.71 minutes, respectively. The ICH Q2(R1) guidelines were followed in the validation of the approach. With correlation values higher than 0.999, linearity was seen in the concentration range of 5–15 μg/mL for Simvastatin and 5-15 μg/mL for Carvedilol. The parameters of linearity, accuracy, precision, robustness, and system suitability were all within reasonable bounds. Simvastatin and Carvedilol in combination tablet dose form were routinely analyzed using the described approach with success.
*Dhaval Kumar Patel (Sun,) conducted a other in Tablet dosage form containing Simvastatin and Carvedilol. RP-HPLC method for simultaneous estimation of Simvastatin and Carvedilol was evaluated on Accuracy and precision of simultaneous quantification of Simvastatin and Carvedilol in tablet dosage form using RP-HPLC. The developed RP-HPLC method showed linearity with R² >0.999, accuracy with 99.7-100.0% recovery for Simvastatin and 99.85-100.18% for Carvedilol, and assay results of 94.32% and 105.54% respectively in tablet formulations.