Development and Validation of Stability Indicating RP-HPLC Method on Core Shell Column for Determination of Degradation and Process Related Impurities of Apixaban—An Anticoagulant DrugReportar como inadecuado




Development and Validation of Stability Indicating RP-HPLC Method on Core Shell Column for Determination of Degradation and Process Related Impurities of Apixaban—An Anticoagulant Drug - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

A rapid, specific, sensitive, and precise reverse-phase HPLC method for the quantitative determination of process related and degradation impurities of Apixaban, an anticoagulant drug is described. The developed RP-HPLC method was successfully applied to the analysis of both Apixaban drug substance and drug product. The chromatographic separation was achieved on a Sigma-Aldrich’s Ascentis Express® C18 4.6 mm × 100 mm, 2.7 μ HPLC column with a runtime of 40 min. Mobile phase-A and mobile phase-B were phosphate buffer and acetonitrile respectively. The column oven temperature was set at 35°C and photodiode array detector was set at 225 nm. Nine process related impurities Imp-1 to Imp-9 have been detected in test sample of Apixaban by using newly developed RP-HPLC method. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to demonstrate the stability-indicating nature of the developed RP-HPLC method. The developed method was validated as per ICH guideline and found to be specific, precise, sensitive and robust.

KEYWORDS

Apixaban, Core-Shell HPLC Columns, RSD and Validation, Stability Indicating

Cite this paper

Landge, S. , Jadhav, S. , Dahale, S. , Solanki, P. , Bembalkar, S. and Mathad, V. 2015 Development and Validation of Stability Indicating RP-HPLC Method on Core Shell Column for Determination of Degradation and Process Related Impurities of Apixaban—An Anticoagulant Drug. American Journal of Analytical Chemistry, 6, 539-550. doi: 10.4236-ajac.2015.66052.





Autor: Shashikant B. Landge1, Sanjay A. Jadhav1, Sunil B. Dahale1, Pavankumar V. Solanki1, Saroj R. Bembalkar2, Vijayavitthal T. Mathad1

Fuente: http://www.scirp.org/



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