Affiliation:
1. Department of Pharmaceutical Quality Assurance, B.K. Mody Government Pharmacy College, Polytechnic Campus, Near Aji Dam, Rajkot-360003, India
Abstract
The objective of the current study was to develop a specific, precise, accurate and robust gradient
stability indicating reversed-phase ultra performance liquid chromatography (RP-UPLC-PDA) assay
method and validated for determination of edoxaban tosylate in API. Gradient separation was achieved
on an acquity UPLC BEH C18 column (50 mm, 2.1 mm and 1.7 μm) column using mobile phase of
acetoitrile:20 mM potassium dihydrogen phosphate, pH 3.0 ± 0.05 adjust with OPA at flow rate of 0.6
mL/min, the injection volume was 1 μL and the detection was carried out of 289 nm by using photodiode
array detector. The drug was subjected to oxidation, hydrolysis, photolysis, and heat to apply
stress condition. The method was linear in the drug concentration range of 100-300 μg/mL with
correlation coefficient of 0.999. Degradation products produced as a result of stress studies did not interfere
with detection of edoxaban tosylate and the assay, thus developed stability indicating method can be
used for routine analysis in pharmaceutical industry.
Publisher
Asian Journal of Chemistry
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