DEVELOPMENT OF STABILITY INDICATING ASSAY METHOD: A REVIEWAbstract
Stability of pharmaceuticals is defined as the ability to retain the quality, purity, Identity, and safety throughout the shelf life of products. It is of main concern because drug substance and products lose its Potency and quality after the time passes, due to change in environmental conditions such as temperature, light, and humidity. It is essential that quality of drugs should maintain throw out the life cycle of drug products for their safe and effective use. The need for constant monitoring of the drug substance and product for their quality and purity has the origin of the development of various stability testing methods. Stability testing now becomes a regulatory requirement for filing NDA and ANDA to USFDA and various regulatory agencies. Stability indicating methods had originated from advancement in various analytical instrument technologies. Stability indicating methods of drug substance and products have the ability for separation, identification, qualification, and quantification of all impurities associated with drug substance and drug product at any storage Conditions to give the exact concentration of drug substance or analyte at any time point over the shelf life of products and beyond. These are helpful to understand the degradation pathways as well as obtaining knowledge about impurities developed during processing which should not be present in drug products or have a specific limit, if present. The present review explored the importance, regulatory requirement, various analytical techniques used and some successfully developed stability indicating methods for different drug substance and drug products.
S. B. Kanthale *, S. S. Thonte and B. B. Supekar
School of Pharmacy, Swami Ramanand Teerth Marathwada University, Nanded, Maharashtra, India.
27 July 2018
01 November 2018
16 October 2018
01 April 2019