Analytical method development and method validation for assay and related compound of pramipexole drug and finish product

Description

The growth of pharmaceutical industry in last three decades has been a pointer towards the requirement of quality medicines to alleviate diseases, ill health and suffering to animals and mankind. The simplest therapy of known organic molecules like aspirin, sulphadiazine and naturally occurring medicines from plant origin have been replaced now by complex organic molecules, which are analogues, derived from multiple synthetic routes. In the event of usage of such molecules the establishment of analytical profile of these molecules together with the desired medicinal activity like safety and efficacy has been the focus of attention of world-renowned scientists and pharmacist.

Drug substances are seldom administered alone, but rather as part of a formulation. Each particular pharmaceutical product is a formulation unique into itself. In addition to the active therapeutic ingredients, a pharmaceutical formulation also contains a number of non-therapeutic agents. These agents are generally referred to as pharmaceutical adjuncts, excipients or necessities, and it is through their use that a formulation achieves its unique composition and characteristic physical appearance.

There are many different forms into which a medicinal agent used for treatment of a disease. Most commonly known dosage forms are capsules, tablets, injections, suppositories, ointments, aerosols and many more including modern drug delivery systems like use of prodrug.

An Analytical chemist used in the many studies and used in this documentation. Drug analysis and assay play important role in the method development, actual manufacture of drug and use of drugs in routine analysis. Drug analysis shows the quality and its specifications which is used for full scale production.