A Review On Chromatographic Method Development And Impurity Profiling
Ashish Phuge , Rekha Bhalerao , Vijaya Barge
1 Department of Pharmaceutical Chemistry, PDEA'S Seth GovindRaghunath Sable College of Pharmacy, Saswad, Pune – 412301, Maharashtra, India. 2 PDEA'S Shankarrao Ursal College of Pharmaceutical Sciences & Research Center, Kharadi, Pune -14, Maharashtra India.
Corresponding Author: Vijaya Barge
E-mail: godse_vijaya@rediffmail.com
Submission: 23.12.2018 Acceptance: 05.01.2019 Publication: 15.02.2019
https://www.doi.org/10.63778/PDEASIJRAAS-ARJCPL/2019_21530
Abstract: Stability indicating assay method (SIAM) is a validated quantitative analytical procedure that can detect changes with time in the properties of the drug substance and drug product under defined storage conditions. It accurately measures the API without interference from other substances and is sensitive enough to detect and quantify even small amounts of degradation products/impurities. To develop a SIAM, stress testing in the form of forced degradation should be carried out as per International Conference On Harmonization (ICH) Guidelines at an early stage so that impurities and degradation products can be identified and characterized. SIAM must be discriminating and properly validated to ensure the accuracy of the long term stability testing study. Impurity profiling includes structure elucidation of organic and inorganic impurities as well as residual solvents in bulk drugs. For the characterisation of impurities various analytical techniques are used such as UV, IR, MS, NMR, Raman and some integrated spectroscopic and chromatographic techniques such as LC/MS, GC/MS, and MS/MS are also used. By using integrated techniques we can propose a structure for the impurity.