Abstract

COMPARISON STUDY OF METHOD DEVELOPMENT AND VALIDATON BY UPLC AND IMPORTANCE OF QbD APPROACH

P. Geetha Bhavani*, Ch. Bibi Sai Vennela, M.V.L Prasanna and Dr. D. Srilakshmi

ABSTRACT

UPLC stands for Ultra Performance Liquid Chromatography. It enhances the chromatographic resolution, speed, and sensitivity analysis. It saves time and decreases the solvent consumption by the use of fine particles. HPLC is the source of UPLC. According to HPLC; as the column particle size decreases, efficiency and resolution are increased. According to the common Van Deemter equation, there is a significant gain in efficiency as particle size reduces to less than 2.5m, and it does not diminish with greater linear velocities or flow rates. Speed and peak capacity (number of peaks resolved per unit time) can be taken to new limits by using smaller particles, which is known as Ultra Performance. It is applicable to forced degradation studies, toxicity studies, analysis of natural products and traditional herbal medicines, amino acid analysis, analysis of drug in human plasma, ADME screening, pesticides in ground water, bioequivalence & bio analysis studies and for drug discovery. In the present review, various drugs that are analysed by UPLC along with the solvent system used is summarised. Quality by Design is constantly searching the ways to ensure and enhance product safety, quality and efficacy. QbD eliminates batch failures and it minimize deviations and costly investigations while avoiding regulatory compliance problems.

Keywords: UPLC, HPLC, QbD, ADME, GC, HETP.