European Journal of Biomedical and Pharmaceutical Sciences

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

*Dhaval Kumar Patel

ABSTRACT

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.

Keywords: Simvastatin, Carvedilol, RP-HPLC, Method Validation, ICH Guideline.