Abstract

APPLYING HPLC - HILIC AS METHOD FOR ANALYSIS OF PHARMACEUTICAL COMPOUNDS

Stefka Ivanova, Lily Peikova, Petya Koleva, Dobrinka Tsvetkova,
Valentina Petkova*

ABSTRACT

HPLC separation method with high sensitivity and selectivity is used as a detector with a large linear range and good reproducibility. It can be applied in order to identify and quantify the main ingredient, "related substances" and impurities. The identity of the target component validation of HPLC required to prove the necessary selectivity, while quantifying and determining the LOD and LOQ is applied for an external certified reference material. Hydrophilic Interaction Liquid Chromatography (HILIC) is the most successful approach for the retention and separation of polar compounds. HILIC has seen a substantial increase in popularity over the last decade, driven by the increase in the development of polar drugs within the pharmaceutical industry and also the growing field of metabolomics, which primarily involves the analysis of polar molecules. This technique has been described as “reversed -reversed phase’” since in HILIC the stationary phase is polar and the aqueous portion of the mobile phase acts as the stronger solvent, which is the opposite of conventional reversed phase chromatography. There are many stationary phases that can be used in a HILIC mode and many phases are generally described as HILIC, independently of their chemistry.

Keywords: HPLC, HILIC, LOD, LOQ, HILIC-MS/MS.