Separation and determination of simvastatin on ZIC-HILIC stationary phases by hydrophilic interaction chromatography in pharmaceutical material products

Abstract

The hydrophilic interaction chromatography (HILIC) technique outperforms other methods in terms of precision and sensitivity. The development and optimization of a HILIC method for validating a separation method for simvastatin estimation in pharmaceutical formulations necessitated determining the optimal mobile phase, buffer concentration, and pH value. The proposed HILIC methods using two columns demonstrated high precision (RSD less than 1%) and a robust linear relationship between the calibration graph and simvastatin concentration ranges of 0.05–4 µg mL−1 with a coefficient of determination (R2) of 0.9996 and 0.9994 for simvastatin. The HILIC methods provided excellent validated LOD (0.023 and 0.015 µg mL−1) and LOQ (0.069–0.045 µg mL−1) values for simvastatin. The HILIC approach was successfully used to estimate simvastatin in commercial pharmaceutical tablets, resulting in an excellent simvastatin recovery > 99%. Using statistical tests, the findings of the HILIC method were compared to the British pharmacopoeia protocol for simvastatin drug. There was no difference in accuracy between the methods.