Development of HPLC-CAD stability indicating assay method for polyethylene glycol-conjugated phospholipid (DMPE-PEG 2000) and identification of its degradation products.

The study introduces first report on a liquid chromatographic method for the quantification of 1,2-Dimyristoyl-sn-glycero-3-phosphoethanolamine-N-[methoxy(polyethylene glycol)-2000] ammonium salt (DMPE-PEG 2000), which is an important constituent of lipid-based nanoparticles. It involves an HPLC-CAD stability-indicating assay method development for DMPE-PEG 2000 and structure elucidation of its degradation products. Hypersil Gold™ PFP column (150 mm × 4.

Development of simple isocratic HPLC methods for siRNA quantitation in lipid-based nanoparticles.

This paper describes the development of simple and user-friendly HPLC methods that can quantitate the amount of small interfering RNA (siRNA) in lipid-based nanoparticle (LNP) formulations. The methods have been used as alternative chromatographic approaches to the size exclusion chromatography in order to perform "fit for purpose" analysis such as determining the amount of released siRNA from LNP formulations as a part of in-vitro release testing. Two HPLC conditions were optimized using reversed phase (a 250 × 4.

Separation of atropisomers by chiral liquid chromatography and thermodynamic analysis of separation mechanism.

In the pharmaceutical industry, the analysis of atropisomers is of considerable interest from a scientific and regulatory perspective. The compound of interest contains two stereogenic axes due to the hindered rotation around the single bonds connecting the aryl groups, which results in four potential configurational isomers (atropisomers). The separation of the four atropisomers is achieved on a derivatized β-cyclodextrin bonded stationary phase.

Determination of polymeric impurities in asunaprevir drug substance and product using size exclusion effect of reversed-phase columns.

This paper describes the development of a simple reversed-phase HPLC method that can quantitate trace amounts of a polymeric degradants (BMT-041910) in asunaprevir drug substance and formulated drug product with quantitation limits of ∼0.05% w/w. The method has overcome several challenges of polymer quantitation such as band broadening, peak coeluting and low sensitivity.

Interactions between a poorly soluble cationic drug and sodium dodecyl sulfate in dissolution medium and their impact on in vitro dissolution behavior.

In the pharmaceutical industry, in vitro dissolution testing ofsolid oral dosage forms is a very important tool for drug development and quality control. However, ion-pairing interaction between the ionic drugand surfactants in dissolution medium often occurs, resulting in inconsistent and incomplete drug release. The aim of this study is toevaluate the effects ofsodium dodecyl sulfate (SDS) mediated medium onthe dissolution behaviors of a poorly soluble cationic drug (Drug B).