It does not cover biochemical or clinical aspects but deals only with unformulated and formulated products. The review continues to be divided into 11 major sections and in some cases subsection either by subtopic or by technique. Because of space limitations, a citation generally appears only in a single section and the articles selected do not represent an exhaustive review of the topics.
GENERAL INFORMATIONExamples of comprehensive books and reviews that have been published in the last two years include the twenty-fifth volume of Analytical Profiles of Drug Substances and Excipients (1), Development and Validation of Analytical Methods (2), and Pharmaceuticals and Related Drugs (3). Three articles have appeared that deal with Assessment of Protein Drugs Obtained by Recombinant DNA Technology (4), Analytical Methods for Peptide Drugs Applicable to Process Control (5), and the purity, stability, and structural characteristics of insulin ( 6). Likewise, several other papers have addressed issues related to reference substances (7), validation (8), and content limits (9). Besides these, two books have been published that cover general aspects of the chromatographic analysis of pharmaceuticals (10, 11) and reviews have appeared that consider more specific chromatographic topics such as drug purity (12), quality control (13), and validation ( 14). The popularity of capillary electrophoretic methods continues to expand as do the number articles that deal with either experimental (15-17) or validation (18-20) issues. Other technique-related reviews have been concerned with flow injection analysis (21), ion-selective electrodes (22,23), ESI and MALDI mass spectrometry (24), scanning probe microscopy (25), thermoanalytical methods ( 26), the analysis of antibiotics by LC/MS (27), and the characterization of polymorphs and solvates by vibrational spectroscopy and nuclear magnetic resonance spectroscopy (28).
ALKALOIDSSeparation-based methods continue to be the most widely used procedures for assaying alkaloids and their formulations. Two papers have been published that deal with optimization and validation of liquid chromatography (LC) procedures for major xanthine (A1) and opium (A2) alkaloids. Likewise, another account has appeared that describes the reversed-phase separation of morphine, codeine, thebaine, papaverine, and noscapine on a base-deactivated octadecyl column in combination with a gradient eluent containing 1-heptanesulfonic acid as the secondary modifier (A3). The morphine content in opium-ipecac tablets also has been evaluated by an alternate method which uses a phenyl bonded phase and a triethlyammonium phosphate buffer-methanol gradient as the eluent (A4). In both methods, each of the gradients takes ∼20 min to complete. A variety of other high-performance liquid chromatography (HPLC) assays have been reported during the last two years. Some examples of these include methods for theophylline and related compounds (A5, A6), atropine and atropine-like alkaloids (A7, A8), bromocriptine mesylate (A9), piloc...