Novel Validated UHPLC Method for the Estimation of Drug Active Compounds
Pp. 44-97 (54)
Mehmet Gumustas, Bengi Uslu and Sibel A. Ozkan
Abstract
Recently, pharmaceutical companies have been driven to create cheaper,
simpler, more novel, and more efficient tools for the discovery, development, delivery,
and monitoring of pharmaceutical active ingredients. In this contest, the development
of sensitive, rapid, and more effective chromatographic methods is vital for analytical
quality control and R&D laboratories. Liquid chromatography (LC) with different
kinds of detection modes are widely used in the pharmaceutical analysis area for the
quantification and identification of active pharmaceutical ingredients in varied
matrices. A completely new version of LC design with improved technology has been
developed, namely ultra-high performance liquid chromatography (UHPLC), which
has evolved from conventional HPLC. UHPLC can be regarded as a new direction for
LC. It is a rather new technique providing new possibilities in liquid chromatography,
especially reducing solvent consumption and decreasing the run times. UHPLC
improves three areas of LC — namely the speed, efficiency, and sensitivity of analysis
by using sub 2 μm particles as a stationary phase. The system is designed as stable in
order to overcome high system pressures while the analysis is performed with no
negative influence on either the analytical column or the other components of the
system. During these days, the quality control of pharmaceutical preparations in
industry is moving one step forward with transferring their methods from HPLC to
UHPLC. The application of UHPLC methods in the pharmaceutical industry introduces
a powerful tool not only for routine analysis but also for clinical approaches. Due to the
high throughput investigation like therapeutic drug monitoring studies, special attention
is paid to the various detection possibilities. In this chapter, the principles, differences,
advantages, and disadvantages of UHPLC are discussed in detail. As a consequence,
pharmaceutical applications via UHPLC are also summarized, based on a survey of the
literature written since 2012.
Keywords:
Active Pharmaceutical Ingredient, Analysis, Dosage Forms, Liquid
Chromatography, Pharmaceutical, Separation, UPLC, UHPLC, Validation.
Affiliation:
Ankara University, Faculty of Pharmacy, Department of Analytical Chemistry, 06100, Tandogan, Ankara, Turkey.
