[Zurück]

A. Chakravarthy:
"Method Development and Validation of Selected Pharmaceutical Drugs by Liquid Chromatography and Spectroscopic Techniques";
Betreuer/in(nen), Begutachter/in(nen): W. Linert, B. Sailaja, K. Niranjan; Andhra University, 2018; Rigorosum: 13.04.2018.

A Pharmaceutical Drug (also referred to as medicine, medication, or simply as drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and relies on the science of pharmacology for continual advancement and on pharmacy for appropriate management.
Drugs are classified in various ways. One of the key divisions is by level of control, which distinguishes prescription drugs (those that a pharmacist dispenses only on the order of a physician, physician assistant, or qualified nurse) from over-the-counter drugs (those that consumers can order for themselves). Another key distinction is between traditional small-molecule drugs, usually derived from chemical synthesis, and biopharmaceuticals, which include recombinant proteins, vaccines, blood products used therapeutically, gene therapy, monoclonal antibodies and cell therapy (for instance, stem-cell therapies). Other ways to classify medicines are by mode of action, route of administration, biological system affected, or therapeutic effects.
Analytical Chemistry is a branch of chemistry that deals with the separation, identification and quantification of chemical compounds. Chemical analysis can be qualitative, as in the identification of the chemical components in a sample, or quantitative, as in the determination of the amount of a certain component in the sample. Analytical chemistry studies and uses instruments and methods used to separate, identify, and quantify matter. In practice- separation, identification or quantification may constitute the entire analysis or be combined with another method. Separation isolates the analyte´s present in the sample.
Pharmaceutical Analysis may be defined as a process or a sequence of processes to identify and/or quantify a substance or drug, the components of a pharmaceutical solution or mixture or the determination of the structures of chemical compounds used in the formulation of pharmaceutical product.
2
Analytical method development and validation are the continuous and inter-dependent tasks associated with the research and development, quality control and quality assurance departments. Analytical method development is the process of selecting an accurate assay procedure to determine the composition of a formulation. It is the process of proving that an analytical method is acceptable for use in laboratory to measure the concentration of subsequent samples. Analytical procedures play a critical role in equivalence, risk assessment and management. It helps in establishment of product-specific acceptance criteria and stability of results. Validation should demonstrate that the analytical procedure is suitable for its intended purpose. Design of experiment is a powerful tool for the method characterization and validation. Analytical professionals should be comfortable to use it to characterize and optimize the analytical method. An effective analytical method development and its validation can provide significant improvements in precision and a reduction in bias errors. It can further help to avoid costly and time consuming exercises.
Analytical instruments play a major role in the process to achieve high quality and reliable analytical data. Thus, everyone in the analytical laboratory should be concerned about the quality assurance of equipment. The most widely used methods for quantitative determination of drugs, metabolites in biological matrices such as blood, serum, plasma, or urine includes Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC),

Pharmaceutical Drugs, Liquid Chromatography