Strategies for peak-purity assessment in liquid chromatography.

Abstract

One of the key requirements for the validation of chromatographic methods is to determine the purity of a chromatographic peak. Statistical modelling of the chromatographic process suggests that overlapping components are highly probable in a chromatogram. Hence extensive efforts have been directed at the development of sensitive, reliable and robust methods to assess peak purity. This is especially the case in the pharmaceutical industry, where liquid chromatography (LC) is widely utilized and the demands on method validation are justifiably high. On-line multiwavelength absorptiometric detection is often used to generate the additional data required to facilitate peak-purity assessment in LC. This approach, using photodiode-array technology, is directly compatible with the aqueous-based reversed-phase LC solvents used extensively in drug analysis. Consequently, this work highlights many of the peak-purity algorithms, which may be applied using LC with diode-array detection. The relative merits of the individual techniques are discussed, and a rationale is developed for their application.