Development of Validated Stability Indicating Assay Method for Pharmaceuticals

Abstract

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. 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. newlineIn this research work attempt has to make to develop stability indicating assay method for Ivabradine and Metoprolol, Glecaprevir and Pibrentasvir, Prucalopride Succinate and Paracetamol and Ibuprofen. Literature review reveals that no stability indicating methods for estimation of selected moieties in bulk and pharmaceutical dosage form were available, very few methods appeared in the literature for the determination of these drugs either in single or in combination with another drugs. In the present investigation the selected drugs were analyzed by simple, sensitive and reliable Reverse Phase High Performance Liquid Chromatographic method. Developed stability indicating assay method was useful for estimation of selected drugs in regular analysis newline