An Overview on LC-MS Chromatography and its Qualification

Abstract

Liquid chromatography and mass spectrometry (LC/MS) is a technique that couples the action of separation of analyte done by liquid chromatography subsequently analysis of separated analyte characteristics done by mass spectrometry. LC/MS is now being put forward by the analyst for the determination of identity, purity, quality, quantity, structural elucidation and molecular weight of unknown compounds. It is a powerful analytical technique that combines the resolution of liquid chromatography with the detection specificity of mass spectrometry. Liquid chromatography (LC) separates sample components and injects them into a mass spectrometer where MS align and detects charged ions. LC-MS also widely being used in evaluation and interpretation of bioavailability, bioequivalence and pharmacokinetic data in bioanalytical studies. LCMS is also playing an important role in the qualitative and quantitative determination of known pollutants, Food safety and development, product quality control such as the quantitation of residual veterinary drugs, food additives and the composition analysis of supplements and organic foods. This review focussed on the qualification of this analytical instrument LC-MS, where Analytical instrument qualification is collective document which provides evidence that instrument performs as per standards suitably for its intended application. Qualification of analytical instrument is usually done regularly on short term or long term to generate a validated data integrity.  As AIQ is a continuous process over lifetime of instrument which comprises of DQ, IQ, OQ, PQ; on risk assessment analysis it provides information on requalification step. When an instrument meet standard, manufacturer functional and operational specification thereby it complies with User Requirement Specification, then an analytical instrument said to a qualified one.