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IJSTR >> Volume 8 - Issue 10, October 2019 Edition

International Journal of Scientific & Technology Research  
International Journal of Scientific & Technology Research

Website: http://www.ijstr.org

ISSN 2277-8616

Analytical Method Development Report For The Determination Of Assay & Related Substances Of Ibutilide Fumarate In Ibutilide Fumarate Injection

[Full Text]



Aakisetti Siva Sankar, Dr. G. Srinivasarao



Ibutilide fumarate, HPLC, API manufactures’s method, Stress testing



The aim of the study is to develop an effective assay to quantify ibutilide fumarate and its related substances in ibutilide fumarate injection. Initially, the API manufacturer’s method was followed which involves two different UV-HPLC assays for both ibutilide fumarate and its related impurities. Upon considering the heat degradation results of the API method, specificity and stability of the known impurities (related substances) was not clearly determined. So the API method was modifiedby using low-pressure gradient UV-HPLCfor accurate detection of ibutilide and its related impurities. The inference of the drug, under various physio-chemical conditions like acid stress, base stress, heat stress, dark and light exposed, peroxide treated, dry heat are also studied. Chromatogram results of the developed method observed to be highly stable and sensitivity as it is able to clearly differentiate the excipient, related impurities and degradation product. Therefore the developed method can be used for the determination of assay and related substances of Ibutilide fumarate in Ibutilide Fumarate injection.



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