Abstract

The pharma market is getting flooded with many new drug formulations as well as fixed dose combination formulations in which different API are there. Each of this is going to contain different types of impurities as well as they are bound to undergo process of degradation by different mechanisms leading to formation of degradation products. All of these are going to be present as impurities. Though the impurities will be within limit in accordance to regulatory authorities, still in case of disease like diabetes and hyper tension the patient is going to be on medicine for rest of his life hence bound to get over exposure to these. Some of which may cause adverse effects like cytotoxic and genotoxic. Hence indeed there is need for identification. In previous era it was ok with regulatory authorities if components in formulation were 99% pure. But know they are insisting on identification of that remaining 1%.

Though there is challenge in front of analytical chemists, use of sophisticated instruments for analysis of impurities has increased and has made task little easier. Scientist are working towards discovering different types of methods whereby accurate results can be obtained. Hyphenated techniques have received tremendous attention as it is been seen as the principal means to solve complex analytical problems. The combined power of separation techniques like chromatography in combination with spectroscopic techniques has been predominantly used over the years for both quantitative and qualitative analysis of unknown compounds. The hyphenated techniques have provided analytical chemist a tool to come over the challenge associated with impurity profiling and determination of safety and efficacy of API. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC)-Mass Spectroscopy (MS), LC-NMR, LC-NMR-MS, GC-MS and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research.

Keywords: Liquid Chromatography (LC); Mass Spectroscopy (MS); Hyphenated Techniques; Force Degradation

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Citation

Citation: Sachin A Pishawikar., et al. “Hyphenated Techniques, an Important Tool for Force Degradation Study". Acta Scientific Pharmaceutical Sciences 4.9 (2020): 23-28.

Copyright

Copyright: © 2020 Sachin A Pishawikar., et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.