Essay about Safe and Effective Pharmaceuticals

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8. Quality, safety and efficacy of drugs
Safety and efficacy of pharmaceuticals are two fundamental issues of importance in drug therapy. The safety of a drug is determined by its pharmacological and toxicological profile as well as the adverse effects caused by the impurities in bulk and dosage forms. The impurities in drugs often possess unwanted pharmacological or toxicological effects by which any benefit from their administration may be outweighed (Nageswara at el., 2003). Therefore, it is quite obvious that the products intended for human consumption must be characterized as completely as possible. The quality and safety of a drug is generally assured by monitoring and controlling the impurities effectively. Thus, the analytical
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Until the beginning of the 20th century, drug products were produced and sold having no imposed control. The quality of medicine was generally poor, their efficacy was uncertain and some were harmful (Nageswara at el., 2003).

10. Role of analytical techniques in quantification of active ingredients and determination of impurities in drugs
10.1 High performance liquid chromatography (HPLC)

HPLC is the premier analytical technique in pharmaceutical analysis, which is predominantly used in the pharmaceutical industry for a large variety of samples. It is the method of choice for checking the purity of new and existing drug candidates, monitoring changes or scaleups of synthetic procedures, evaluating new formulations, and scrutinizing quality control/assurance of final drug products.
HPLC is used to analyze, identify, separate, purify & quantify the compounds. Currently it is the most widely used analytical technique for the quantitative and impurity analysis of a vast majority of pharmaceuticals, biomolecules, polymers, and other organic compounds (Ahuja and Dong, 2005). It offers the desired sensitivity for trace level determinations with a high degree of automation. A wide variety of stationary phases and operation modes make analytical technique applicable to all drug classes. The typical detection limits for drug-related impurities by HPLC are 0.1% or lower and this can be routinely met in
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