Development and Validation of Novel Sensitive and Stability Indicating Analytical Methods for Different Active Pharmaceutical Ingredients using Modern Techniques

Abstract

Drug is the substance other that intended for use in the diagnosis, prevention, cure, and treatment of disease. It also intended to affect the structure or function of the body. The study of drugs are comes under pharmaceuticals and medicinal chemistry. The drugs are used to making difference in the patient welfare. No any single drug is totally safe but it is being efficient to use based on benefits over adverse effects. In the drug development processes, fundamental decisions are taken based on the data acquired from analytical methods. The challenges faced in separation and identification of drugs having impurities with similar chemical properties with identical behavior in the separation science. The testing of every marketed drugs, its analytical method is to be selective, precise, accurate, robust and stability indicating. In the drug substances as well as drug products, separations of impurities which may form during storage conditions bring the development of analytical methods at the initial stage, if it is not focused at the beginning. Keeping this in view, an attempt has been made to develop the various analytical methods for separation of impurities, which is also stability indicating for the active pharmaceutical ingredient (API). newlineTo design a quality product and its manufacturing process to consistently deliver the intended performance of the product. The information and knowledge gained from pharmaceutical development studies and manufacturing experiment provide scientific understanding to support the establishment of the design space, specification and manufacturing control. Information from pharmaceutical development studies can be basis for quality risk management. It is important to recognize that quality cannot be tested into products; i.e. quality should be built in by design. Changes in formulation and manufacturing processes during development and lifecycle management should be looked upon as opportunities to grain additional knowledge and further support establishment of the design space. newlineT