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About High Performance Liquid Chromatography Analysis

High Performance Liquid Chromatography (HPLC) is an analysis technique used for separation and quantification of small molecules and polymers.  HPLC is the method of choice for testing complex mixtures containing non-volatile and semi-volatile organic compounds such as polymer additives, active pharmaceutical ingredients (API’s), and impurities.  HPLC employs a liquid mobile phase that flows through a column packed with support particles that are coated with a stationary phase that separates the chemical compounds present in the sample.

  • Applications of HPLC

    • Analysis of polymer additives (antioxidants, light stabilizers, photoinitiators, plasticizers)
    • Extractables & Leachables Testing
    • Assay, purity, and stability testing of Active Pharmaceutical Ingredients (API’s) and excipients in drug formulations
    • Drug stability testing
    • Analysis of flame retardants in plastics and fabrics
    • Testing for residual monomers such as Bisphenol-A
    • Food quality and food safety testing
    • Analysis of preservatives in cosmetics
    • Size exclusion chromatography (SEC)/gel permeation chromatography (GPC) analysis of polymer molecular weight distributions
    • Explosive residue analysis

    Detectors:

    • Ultraviolet/Visible Absorbance (UV/Vis)
    • Photodiode Array (PDA)
    • Refractive Index (RI)
    • Evaporative Light Scattering (ELSD)
    • Fluorescence
    • Mass Spectrometry (LC-MS)

  • Sample Considerations

    HPLC is applicable to solid or liquid samples.

    Samples must be dissolved or diluted or extracted with an appropriate solvent prior to HPLC analysis.

    Sample cleanup or enrichment using solid-phase extraction (SPE) may be employed before HPLC analysis.

    Derivatization of the target compound(s) may be required to attach chromophores that absorb UV or visible light.

  • Experience

    • Identification and quantification of antioxidants, UV absorbers, and hindered amine light stabilizers (HALS) in plastics
    • HPLC method development
    • HPLC method validation
    • GMP compliance testing according to compendial methods (USP and EC)
    • Assay and purity testing of API’s and excipients
    • Analysis of glycerol monostearate (GMS) concentration in polypropylene films and molded parts
    • Formaldehyde emission testing of products
    • Competitor product analysis (deformulation)
    • Migration testing for food contact approval
    • Analysis of photoinitiator leaching from syringe labels