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 separa tion method for simvastatin estimation in pharmaceutical formulations necessitated determining the optimal mobile phase, buffer concentration, and pH value. The proposed HILIC methods using two col umns demonstrated high precision (RSD less than 1%) and a robust linear relationship between the cal ibration graph and simvastatin concentration ranges of 0.05–4 mg 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 mg mL 1 ) and LOQ (0.069–0.045 mg 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 accu racy between the methods. Copyright 2021 Elsevier Ltd. All rights reserved. Selection and peer-review under responsibility of the scientific committee of the Indo-UK International Virtual Conference on Advanced Nanomaterials for Energy and Environmental Applications (ICANEE 2020)