Analytical Method Verification and Optimization of an Assay of Sugammadex Sodium API by RP-HPLC

Abstract

The foundation of High Performance Liquid Chromatography (HPLC) is the affinity principle. In pharmaceutical enterprises and laboratories, the HPLC technology was utilized to separate the API and excipients and determine their purity and quantity. One of the most sophisticated methods in the current world is HPLC, which uses two analytical techniques: qualitative analysis and quantitative analysis. In the HPLC, the mobile phase and stationary phase play the most important roles. Natural interactions between the solute and stationary phase can result from a variety of forces, including electrostatic, vanderwall, hydrophobic and hydrogen bonding forces, among others. The chromatographic representation should be utilized to identify the result. The different detectors employed in HPLC include mass spectrometer, photodiode array detectors, UV-visible detectors and refractive index detectors. Both polar and non polar compounds are present in these two phases, which are the reverse phase and normal phases. Affinity decreases result in polar to polar and non-polar-to-non- polar interactions. However, the increase in affinity is caused by the polar to non polar interaction.

Method: Using Shimadzu's isocratic program and instrumentation, the process was optimized for the assay of Sugammadex. a C18,4.6 x 250 mm 5µm Waters symmetry column equipped with a UV detector with a wavelength of 254 nm.

Results: The Optimize of method of Sugammadex API in accordance with the ICH Q2R(1) guideline. The assay result were found to be 1.756% was observed within the limit of <2.0%.