Analytical Method Development and Validation

A number of drugs are introduced in the market every year, also many new fixed dose combinations of already individually approved drugs are formulated with an aim to achieve better therapeutic efficacy. Pharmaceutical products formulated with more than one drug, typically referred to as combination products, are intended to meet previously unmet patients need by combining the therapeutic effects of two or more drugs in one product. These combination products can present daunting challenges to the analytical chemist responsible for the development and validation of analytical methods Many times few combinations do not have any official methods for simultaneous analysis of their "active pharmaceutical ingredients". This is because there is a time lag between the introduction of the drug into the market and its inclusion in the pharmacopoeias. Hence it becomes necessary to develop newer analytical methods for routine analysis of these drugs which will help to ensure the identity, purity, potency and performance of the drugs in the dosage forms.