Pharmaceutical Analysis

Nanostream, provider of products and services that increase productivity in laboratories at pharmaceutical and biotech companies, extends its global reach to Europe by establishing a sales and support office in The Netherlands.

The effect of switching between high and low pH mobile phases on a single analytical HPLC column was investigated. The ability to rapidly switch between pH extremes on XBridge columns without special washing/re-equilibration steps dramatically reduces the time for separation of pharmaceutical compounds.

Cleaning validation is a major analytical application in the pharmaceutical industry. Here, high performance liquid chromatography (HPLC) with charged aerosol detection is compared and contrasted to HPLC with UV detection showing comparable performance and several advantages for charged aerosol detection, especially for analytes that do not contain a chromophore.

Phenomenex, Inc., a global leader in the separation sciences business, has been notified by R&D Magazine that it has won the coveted R&D 100 Award for the second year in a row.

This article describes the use of ultrahigh-pressure liquid chromatography (UHPLC) in pharmaceutical analysis of drug substances and drug products with UV absorption detection.

Mass overload is related to the mass of sample that can be injected before the stationary phase is sufficiently loaded to cause changes in the chromatography.

The concept of membrane-controlled processes is widespread in nature. Nearly all biological mechanisms concerning mass transport and exchange are regulated by membrane barriers and a variety of technical and biotechnological applications have been devised based on this mechanism. Membrane applications in analytical chemistry are geared towards the enrichment of target substances from an aqueous solution or the separation of compounds from a complex matrix. This article describes membrane-assisted extraction processes to separate traces of polar pharmaceutical substances the so called emerging micropollutants from aqueous samples. Basic prospects and examples of membrane-supported extractions are presented.

Mixed mode chromatography combines aspects of ion exchange chromatography and conventional reversed-phase (RP) chromatography. The combination of both hydrophobic and ion-exchange properties allows for independent control of retention for ionizable and neutral molecules.

Detector selection for a method should be made on a case-by-case basis.

LC-MS-MS has become a widely used technique for the fast and sensitive quantitation of small molecules. In this article, this approach has been extended to high-throughput quantitative LC-MS-MS analysis under GLP applications for a drug candidate in development from preclinical animal studies through clinical development.

Bob Wiedemer, Grace Davison Discovery Sciences

Xiaodong Liu and Christopher Pohl, Dionex Corporation

Eric S. Grumbach, Diane M. Diehl and Jeffrey R. Mazzeo, Waters Corporation

Fast, reliable measurements of lipophilicity has a great impact on the compounds' selection process at an early stage of dug discovery. The guest columnit examines HPLC methods for this purpose.

Separation instrument techniques are among the most widely used technologies in the analytical instrumentation market. They span the entire industrial and regional marketplace. The lab separations market includes chromatographic techniques such as analytical and preparative HPLC, GC, IC, TLC, flash, and low pressure LC.

In the mid 1980s the chromatographic application of gases compressed (or liquefied) to supercritical state was tested by research teams from several analytical instrument manufacturers. The recently introduced capillary columns seemed ideal candidates on which to perform such supercritical fluid chromatography (SFC) methods.

A reluctance to make any changes to a validated or compendial method is common, and often well founded.

Excess variability is not acceptable in a pharmaceutical method.

This article gives an overview of the performance of a previously developed system for the ranking of C18 reversed-phase columns applied to different pharmaceutical analyses. The separation of eight different drug substances from their respective impurities was studied. The chromatographic procedure for acetylsalicylic acid, clindamycin hydrochloride, buflomedil hydrochloride, chloramphenicol sodium succinate, phenoxymethylpenicillin and nimesulide was performed according to the corresponding European Pharmacopoeia monograph. The separations of dihydrostreptomycin sulphate and vancomycin were performed according to literature. It was found that that the column ranking system is a helpful tool in the selection of suitable columns in these analyses.

Measurement of chiral purity is a necessary means of quality control for drug substances that exhibit chiral centers. This article describes a simple and practical approach to setting up system suitability and validation for chiral purity assays.

Dissolution testing is a mandatory test for the physical evaluation of solid dosage forms such as capsules, tablets, ointments, and creams. The most basic form of testing measures the rate of dissolution or solubility of a drug tablet. Dissolution testing also can be used in ADME and bioavailability studies, release rates of a drug substance under different conditions, as well as provide information as to the efficacy of in-vivo performance.

September 2006. Top-down and bottom-up are alternative strategies for protein identification and characterization by mass spectrometry. How do they fit into the world of proteomics? What are their implications for separation technology? These questions are addressed in this installment of "Directions in Discovery."

The market for high performance liquid chromatography (HPLC) continues to be one of the most dynamic markets of the analytical instruments industry. A few years ago, the HPLC market began showing signs of maturity with little product innovation and slower growth rates. Although innovations in mass spectrometry (MS) helped to fuel growth, HPLC was an afterthought and considered to be a mere inlet to MS. However, the recent development of fast liquid chromatography (LC) systems is energizing the HPLC market.