ISSN : 2663-2187

Stability Indicating Methods For Estimation Of Various Drugs In Bulk And Pharmaceutical Dosage Forms

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Pulla Sivakumar, Jonnakuti Yacobe, Tirunagari Srinivasa Rao, Vegi Sridhar
ยป doi: 10.48047/AFJBS.6.Si4.2024.5812-5827

Abstract

Stability-indicating methods are methods used to determine the quantity of APIs in the formulation as well as to identify degradants. These include the stability indicating methods, their importance, the theory behind them, the techniques used in them, the steps in the development and validation of such methods, and the applications of the various stability-indicating methods available. Some of the general types of analytical methods include thin-layer chromatography (TLC), high performance liquid chromatography (HPLC), gas chromatography (GC), ultraviolet visible spectroscopy (UV-Vis), infrared spectroscopy (IR), mass spectrometry (MS), capillary electrophoresis (CE) and nuclear magnetic resonance spectroscopy (NMR). The regulatory bodies have carried out their mandates and put more emphasis on stability indicating methods to enhance the quality, safety and efficacy of drugs. Method development is therefore the process of choosing the right method, tuning the parameters for the method, and ensuring that the method works optimally. Stress tests are acid/base hydrolysis, oxidation, photolysis, and heat to the API to identify the degradation studies. Application types look at pills that are taken orally, substances that are injected, creams that are applied externally, and aerosols that are inhaled. Case studies illustrate the approach for creating stability indicating methods for certain active pharmaceutical ingredients. Issues such as method specificity and automated analysis are discussed as well. New trends and improvements in green analytical chemistry and high-throughput methods are presented. The abstract highlights theoretical and practical aspects related to stability indicating method development, validation, and applications of method of analysis in pharmaceutical science.

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