Novel Validated UHPLC Method for the Estimation of Drug Active Compounds

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.