Review on Pharmaceutical Impurities, Stability Studies and Degradation Products: An Analytical Approach

The development of the pharmaceuticals brought a revolution in human health. These pharmaceuticals would serve their intended only if they are free from the impurities and are administered in appropriate amount. With increasing regulatory strictness on the control of drugs, impurities and their degradation products in pure and formulated products, a deep stress is being given on the need of the stability indicating methods to estimate the drugs and their impurities by using variety of analytical instrumental methods. Ranging from the classical TLC methods to the modern hyphened techniques, such as liquid chromatography-mass spectrometry, gas chromatography-mass spectrometry etc. each and every technique play its part in estimating the drugs, and analyzing their impurities, which could possess a threat to human life. Analytical instrumentation also plays an important role in checking the stability of the drugs in variety of environmental condition and finalizing the expiration date of the drugs in pure and formulated form. This write-up reviews the literature for application of various analytical tools in the study of impurities, stability study and degradation products in pharmaceuticals.