RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF SIMVASTATIN AND CARVEDILOL IN TABLET DOSAGE FORM

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.