Chromatography Techniques

Chromatography-HPLC in Pharmaceutical Analysis

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One of the most characteristic features of the development in the methodology of pharmaceutical and biomedical analysis is that HPLC became undoubtedly the most important analytical method for identification and quantification of drugs, either in their active pharmaceutical ingredient or in their formulations during the process of their discovery, development and manufacturing.

Drug development starts with the discovery of a molecule with a therapeutic value. This can be done by high throughput screening during which separations by fast or ultra-fast HPLC are performed. At the discovery stage there can be also characterizing synthetic or natural products. Drug metabolism and pharmacokinetics (DMPK) is the step where the candidate compounds for drug are tested for their metabolism and pharmacokinetics. The studies involve use of LC-MS or LC-MS/MS. The goal in the discovery stage of drug development is to discover a new, safe and active chemical entity (NCE) that will become medication for diseases. During the last decade parallel synthesis of potential lead compounds, using combinatorial chemistry has been done. Due to its high sensitivity and selectivity, HPLC coupled with tandem mass spectrometry, HPLC-MS/MS has become the predominant method in bioassays, and pharmacokinetic and metabolic studies.

Chromatography and spectroscopy are orthogonal techniques, i.e. their types of information are very different and are specific. Chromatography is a separation method and spectroscopy is a technique which yields a ‘fingerprint’ of individual or from mixture of molecules. HPLC is a technique for separation, quantification and identification of components in a mixture. It is especially suitable for compounds which are not easily volatilized, thermally unstable and have high molecular weights. The advantage of UV method over HPLC method is that the UV method does not require the elaborate treatment and procedures usually associated with chromatographic method. It is less time consuming and economical. The HPLC and UV spectrometry methods are adequate methods to quantify a drug in pure form and its dosage form. Since these methods are simple, specific, rapid, precise and accurate, they may be successfully and conveniently adopted for routine quality control analysis of drugs in bulk and pharmaceutical dosage form.