A validated, stability-indicating HPLC method for the determination of dexamethasone related substances on dexamethasone-coated drug-eluting stents

Journal of Pharmaceutical and Biomedical Analysis
Quan ChenSteve Nowak

Abstract

An HPLC method was developed and validated to determine trace amounts of dexamethasone related substances on dexamethasone-coated drug-eluting stents. Separation of dexamethasone from its major process impurities and degradation products was achieved on a Zorbax Eclipse XDB C8 column using gradient elution and UV detection at 239 nm. The method was validated according to ICH guideline requirements. In addition, stent extraction efficiency, solution stability and method robustness were evaluated. The method was determined to be linear in the range of 0.01-0.30 microg ml(-1) for the quantitation of major dexamethasone related substances. Method accuracy was assessed by spiking dexamethasone acetate at three levels over the range of 0.025-0.175 microg ml(-1). The dexamethasone acetate recovery ranged from 89.6 to 105.8%. The intermediate precision over the three levels was less than 6% (n=9). The method was also shown to be repeatable at concentration levels of 0.025, 0.125 and 0.175 microg ml(-1) dexamethasone with relative standard deviation values of 4.1, 1.7 and 1.6%, respectively. The method was found to be specific, stability-indicating, and sensitive with a detection limit of 0.008 microg ml(-1) and a quantitation limit of ...Continue Reading

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Citations

Aug 24, 2013·Journal of Pharmaceutical and Biomedical Analysis·Deepti Jain, Pawan Kumar Basniwal
Jan 28, 2014·Journal of Pharmaceutical and Biomedical Analysis·Jessica Fiori, Vincenza Andrisano
Mar 5, 2015·International Journal of Analytical Chemistry·Ali Mohammad Akhoundi-Khalafi, Masoud Reza Shishehbore
Feb 14, 2015·The Journal of Orthopaedic and Sports Physical Therapy·Justin H RigbyGary W Mack
Jun 25, 2014·Environmental Technology·Saleh SulaimanaRafik Karaman
Jan 5, 2014·Journal of Pharmaceutical and Biomedical Analysis·Lakkireddy PrakashR Haribabu
Mar 10, 2020·Journal of Biomaterials Science. Polymer Edition·Kritika Nayak, Manju Misra
May 29, 2015·Optometry and Vision Science : Official Publication of the American Academy of Optometry·Kuan-Hui Hsu, Anuj Chauhan
Apr 23, 2020·Journal of Athletic Training·Justin H RigbyChang Ji
Oct 30, 2020·Journal of Sport Rehabilitation·Brady M SmithJustin H Rigby
Jan 31, 2020·Saudi Pharmaceutical Journal : SPJ : the Official Publication of the Saudi Pharmaceutical Society·Preeti PandeyHarendra S Parekh
Jan 7, 2021·Tissue Engineering. Part a·Jia-Pu LiangCherie L Stabler
Oct 2, 2021·Drug Delivery·Ghazala BegumRichard James Blanch

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