“…CE has been applied for determination of pravastatin in fermentation broth in order to optimize its production in bioreactors [105]. Pravastatin is produced in two-step fermentation.…”
“…CE has been applied for determination of pravastatin in fermentation broth in order to optimize its production in bioreactors [105]. Pravastatin is produced in two-step fermentation.…”
“…a Zorbax SB-C18 (50 mm x 4.6 mm, 1.8 m) in terms of analysis time, sensitivity and reproducibility. Both columns operated with similar performance except the sensitivity was higher and gradient equilibration times and column stabilization times were longer in the particle based column, while the solvent consumption was strongly increased when using the monolithic column [108].…”
Section: Monolithic Silica Columns In Quality Controlmentioning
In recent years, a trend of change has been observed within pharmaceutical industry. As modern drug discovery has reached a remarkable level of complexity and drugs need to be discovered, developed and produced against strict timelines and within cost- and regulatory constraints, industry seeks "lean" solutions to increase productivity. Among them, increasing the sample throughput of the ever-growing number of necessary (routine) analyses has become a popular target to cut precious time. For the last thirty years, High-Performance Liquid Chromatography (HPLC) has been the leading technology when it comes to various analyses in pharmaceutical industry; however, its necessity of serial analyses taking typically 10-45 min has been a sample throughput-limiting barrier. Lately, the fundamentals of HPLC have been exploited to raise new technologies that can speed up analyses to ground breaking limits, without compromising separation efficiency. This paper reviews some promising technologies, i.e. totally porous sub-2microm particles accompanied by pressures up to 1000 bar (Ultra-Performance Liquid Chromatography or UPLC), fused-core particle technology, monolithic supports and High Temperature Liquid Chromatography (HTLC), having the potential to take LC to the next level in pharmaceutical industry. As each analytical method has its own demands, the advances of the above technologies are discussed for different applications in pharmaceutical analysis where high-throughput analysis can be meaningful, i.e. in a drug discovery and development setting, and in quality operations. Both chemical and biological pharmaceuticals are considered. We discuss the perspectives of these technologies and their realizations up to now in high-throughput pharmaceutical analysis.
“…A comparative study to assay pravastatin [59] in fermentation broth by RP-HPLC with a Zorbax SB-C18, 1.8 mm particulate silica column, and a monolith column was completed. The methods were found to have similar selectivity, but higher sensitivity was found and longer equilibration times were required with the sub-2 mm particulate silica column and the solvent consumption was significantly higher with the monolithic method.…”
& The need for pharmaceutical analytical laboratories to increase sample throughput and speed of analysis to meet accelerated drug development timelines has led to considerable interest in the development of fast liquid chromatographic technology. Fast liquid chromatographic pharmaceutical analysis is accomplished by developments in ultra-fast high performance liquid chromatographic instrumentation, emerging technologies in column stationary phases and high temperature liquid chromatographic analysis. This review provides an overview and gives recent developments and applications in the different strategies used in fast liquid chromatographic pharmaceutical analysis.
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