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 activities concerning quantification of active ingredients and impurities in drugs are among the most important issues in modern pharmaceutical analysis (Nageswara at el., 2003).
9. Regulatory aspects
To guarantee the quality, clinical performance, efficacy, and safety of a pharmaceutical product, specifications are fixed and approved by the competent regulatory authorities of each country in which the drug is marketed. Analytical testing ensures that these specifications are met by confirming the identity, purity, and potency of drug substances and drug products prior to their release for commercial use. To assure reliable bioavailability, drug products' performance testing is needed (Ahuja and Dong, 2005). This performance testing comes in the form of either dissolution or disintegration tests.
In the UK the MHRA is an executive agency of the Department of Health that sets the standards of safety, quality and performance of drugs for human use. All licensed medicines in the UK are evaluated by the MHRA to ensure that acceptable standards on safety, quality and efficacy are met (MHRA, 2009). Control of medicine quality is more important today than ever before. 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...