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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 photo-diode 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.
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References
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References
Z.A. Stacy, W.B. Call, A.P. Hartmann, G.L. Peters and S.K. Richter, Edoxaban: A Comprehensive Review of the Pharmacology and Clinical Data for the Management of Atrial Fibrillation and Venous Thrombo-embolism, Cardiol. Ther., 5, 1 (2016); https://doi.org/10.1007/s40119-016-0058-2
R. Maheswaran, Scientific Considerations of Forced Degradation Studies in ANDA Submissions, J. Validation Technol., 18, 92 (2012).
H. Brummer, How to Approach a Forced Degradation Study, Life Science-Technical Bulletin, 31, 1 (2011).
K. Huynh-Ba, Handbook of Stability Testing in Pharmaceutical Development, Springer, p. 141 (2010).
A. Paola, E. Tonhi and P. Silva, Quality Control of Herbal Medicines and Related Areas, Bioagri Laboratórios, p. 25 (2011).
ICH Harmonized Tripartite Guidelines, Validation of Analytical Procedures: Text and Methodology, Q2(R1) (2005).
G.G. Kalyankar, P.H. Vansiya, K.B. Bodiwala, S.R. Lodha, P.B. Prajapati and K.M. Ranch, Development and Validation of Spectrophotometric Method for the Estimation of Edoxaban Tosylate Monohydrate in its Synthetic Mixture, Am. J. PharmTech Res., 8, 296 (2018); https://doi.org/10.46624/ajptr.2018.v8.i3.022
P. Reddy, V.S. Jagarlapudi and C. Sekaran, Determination of Edoxaban in Bulk and in Tablet Dosage Form by Stability Indicating High-Performance Liquid Chromatography, Pharm. Sci., 22, 35 (2016); https://doi.org/10.15171/PS.2016.07
W. Zhang, D. Lou, D. Zhang, Y. Zhang and H. Huang, Determination of Rivaroxaban, Apixaban and Edoxaban in Rat Plasma by UPLC–MS/MS method, J. Thromb. Thrombolysis, 42, 205 (2016); https://doi.org/10.1007/s11239-016-1367-y
B. Arous and M.A. Al-Mardini, UPLC-MS Stability-Indicating Method for Determination of Edoxaban and its Acid Degradation Products, Acta Sci. Pharm. Sci., 3, 73 (2019).