Characterization of poloxamers by reversed-phase liquid chromatography

Abstract

We developed a novel reversed-phase liquid chromatography method for monitoring multiple ingredients in poloxamers and evaluating their stability.

Development of a rapid and reliable analytical method for screening poloxamer 188 for use in cell culture process

“…In this work, RPLC was pursued as a viable approach to develop a quality control impurity limit method for poloxamer P188. RPLC was pursued over SEC as various chromatographic variables (column, mobile phase compositions, and gradient conditions) can be optimized . Poloxamers are chemically synthesized in two steps, where differences in polymerization rates result in the polydispersion and heterogenous nature of poloxamer species .…”

“…While the laborious 14‐day shake flask use test has been adopted across the biopharmaceutical industry as an impurity quality control (QC) release method for poloxamer P188, it is time and resource consuming and has not been optimized for sensitivity among the various cell lines. Two orthogonal chromatographic methods, SEC and RPLC, have been reported to detect the impurity responsible for the loss of shear protection. Although useful, these analytical methods are not designed for quick analysis and lack detection sensitivity for low level impurities.…”

“…Although useful, these analytical methods are not designed for quick analysis and lack detection sensitivity for low level impurities. While separation of various poloxamer fractions can be achieved with a reversed phase C18 column, a C3 column was selected as the primary method objective was to isolate the shear protectant inhibitor impurity fraction from the main fraction. Charged aerosol detection (CAD) was also selected as the preferred detection mode as poloxamers lack a strong chromophore.…”

Thermosensitive biomaterial gels with chemical permeation enhancers for enhanced microneedle delivery of naltrexone for managing opioid and alcohol dependency

“…High performance liquid chromatography (HPLC) assays 5-DTAF reaction and isolation efficiency was analyzed using reverse-phase HPLC on a Shimadzu Prominence i-Series LC-2030 Plus system with UV detector (Shimadzu, Torrance, CA, USA), outfitted with a C-18 column (5 µm particle size, 100 Å pore size, 150 mm length, 4.6 mm inner diameter) (Phenomenex®, Torrance, CA, USA). The mobile phase, based on Gaun et al, 13 consisted of 40 : 60 acetonitrile : water from 0 to 3 min, gradually increased acetonitrile from 40 : 60 to 99 : 1 acetonitrile : water from 3 to 12 min, then equilibrated back to 40 : 60 acetonitrile : water for 8 min before injecting the next sample. Fluorescence intensity was measured by exciting at 592 nm and detecting at 516 nm.…”