HPLC laboratory productivity

Today, Fast LC is the easiest way to increase HPLC laboratory productivity by 3-5 fold without sacrificing resolution, sensitivity, or assay reliability.19 Figures 3.18-3.20 demonstrate the versatility and dramatic speed achievable with Fast LC. Chapter 4 discusses the effect of extracolumn band-broadening... 

This chapter discusses regulatory issues in HPLC laboratories with a focus on procedures and requirements for system qualification, calibration, method validation, and system suitability testing. Examples in a cGMP pharmaceutical environment are used to illustrate the various tools and systems used to ensure the degree of HPLC data accuracy necessary to achieve the delicate balance of regulatory compliance and laboratory productivity. 

Parallel analysis is one of the most effective ways to enhance laboratory productivity. A typical parallel analysis HPLC system consists of multiple pumps or a multi-channel pumping system, a multi-probe autosampler capable of four or eight simultaneous parallel injections from 96-well microplates, and a multiplexed UV detector and/or MS. This generic approach allows a 4 to 8 fold increase of sample throughput while maintaining the traditional performance and convenience of HPLC. This technology can potentially be extended to a 96-channel analysis system. 

While automated tools and software are available for system qualification, method validation, and system suitability testing, achieving regulatory compliance for an HPLC laboratory remains a complex, costly, and time-consuming process. Many companies are adopting a risk-based approach to balance productivity and compliance. For instance, many pharmaceutical research... 

If the hGH is exported to the culture medium the product can easily be collected by removal of the cells from the culture medium by centrifiigation. Purification of hGH from the culture medium is faciUtated by low amounts of contaminating proteins present. In fact, it has been shown that hGH can be purified on a laboratory scale by a single purification step on a reversed-phase hplc column (43). Mammalian cells growing in tissue culture have also been used as hosts to produce hGH, which is exported into the culture media (44). 

The theobromine and caffeine contents of several finished chocolate products as determined by hplc at Hershey s laboratories are presented in... 

High-pressure liquid chromatography (HPLC) is used to separate and purify the products of laboratory reactions. 

A quality control laboratory had a certain model of HPLC in operation. One of the products that was routinely run on the instrument contained two compounds, A and B, that were quantitated in one run at the same detector wavelength setting. At an injection volume of 20 /tL, both compounds showed linear response. The relatively low absorption for compound B resulted in an uncertainty that was just tolerable, but an improvement was sought. 

The 3,4-dihydrodiol is a major component of the free dihydrodiols formed in mouse skin maintained in short-term culture (28). The optical purities of these dihydrodiols were determined by a CSP-HPLC method (43). The metabolic fates of the enantiomeric DMBA 3,4-dihydrodiols are not yet known. Studies in our laboratory indicate that the products formed in liver microsomal metabolism of DMBA 3,4-dihydrodiol bind extensively to the components of liver microsomes and the expected 1,2,3,4-tetrols of DMBA were not detected in the acetone/ethyl acetate extract of the incubation mixture (unpublished results). It is known that these products bind extensively to DNA... 

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