Solanki, P.V., Uppelli, S.B., Dhokrat, P.V. and Mathad, V.T. (2015) Investigation on Polymorphs of Apixaban, an Anticoagulant Drug: Study of Their Transformations and Designing Efficient Process for Their Preparation. World Journal of Pharmaceutical Science, 3, 663-677.

has been cited by the following article:

• TITLE: 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

  AUTHORS: Shashikant B. Landge, Sanjay A. Jadhav, Sunil B. Dahale, Pavankumar V. Solanki, Saroj R. Bembalkar, Vijayavitthal T. Mathad

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

  JOURNAL NAME: American Journal of Analytical Chemistry, Vol.6 No.6, May 13, 2015

  ABSTRACT: 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.