Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
47, Number 6, July 2009, pp. 443-451
Accelerating the Quality Control of Pharmaceuticals
Using Monolithic Stationary Phases: A Review of Recent HPLC Applications
Constantinos K. Zacharis
Laboratory of Analytical Chemistry, Department of Chemistry,
Aristotle University, GR-54124, Thessaloniki, Greece
High-performance liquid chromatography (HPLC)
is the predominant technique in the quality control of pharmaceutical
formulations. HPLC offers highly sensitive and selective analytical
methods with increased robustness and separation efficiency.
The majority of HPLC-based methodologies are based on the usage
of particulate-based columns and cannot be applied at elevated
flow rates (> 2 mL/min) due to excessive back-pressure. Therefore,
the typical duration of separation cycles is in the range of
5–30 min, making most assays time-consuming, especially
when a lot of samples have to be analyzed in a minimum amount
of time. Monolithic stationary phases for HPLC offer a very interesting
alternative to conventional particulate-based columns. The size
of the skeleton and the distribution of the pores of monolithic
materials offer the possibility of developing efficient separation
protocols at higher flow-rates due to the low pressure-drop across
the column. The present review intends to cover the applications
of monolithic based HPLC stationary phases in the quality control
of pharmaceutical formulations, including identification of active
pharmaceutical ingredient, assay, purity, dissolution, blending,
and dosage uniformity, etc.
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