Handbook of Pharmaceutical Analysis by HPLC: Volume 6 : Michael Dong :This study presents the role of assay methods in characterizing the quality of bulk substances in pharmaceutical analysis. High-performance liquid chromatography HPLC is the most remarkable development and the technique has become very significant in the quality control of bulk drugs and pharmaceutical formulations, even at the pharmacopoeial level. Development of HPLC and other chtromatographic techniques, coupled with mass spectrometry, is also useful in the determination of drugs and their metabolites in biological samples. The role of electrophoretic, spectroscopic, and other methods in pharmaceutical analysis are discussed here. There are separate sections devoted to microscopy techniques that are useful in the pharmaceutical field, as also the regulatory aspects of drug analysis, with emphasis on questions related to validation. In the field of drug analysis, the analytical investigation of bulk drug materials, the intermediates in their synthesis, products of drug research, drug formulations, impurities and degradation products, and biological samples containing the drugs and their metabolites is a very important area of research.
The role of assay methods in characterizing the quality of bulk pharmaceuticals
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High pressure liquid chromatography-frequently called high performance liquid chromatography (HPLC or, LC) is the premier analytical technique in pharmaceutical analysis and is predominantly used in the pharmaceutical industry.
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HPLC- Method Development and Validation
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