VALIDATED RP-HPLC STABILITY-INDICATING METHOD OF ANTICOAGULANT ACTIVE PHARMACEUTICAL INGREDIENT; APIXABANAbstract
A simple and precise stability-indicating reversed-phase (RP-HPLC) method was developed and validated for the determination of Apixaban active pharmaceutical ingredient. The chromatographic condition was carried out on Phenomenex Luna 5 µm C18 100 Å (150 × 4.6 mm) HPLC column with prepared buffer solution 1.0 ml of Orthophosphoric acid mixed with 0.2% of potassium dihydrogen phosphate solution, use as mobile phase (a), mobile phase (b) was acetonitrile. The mobile phase flow rate at 1 ml/min and the detection wavelength is 230 nm. Forced degradation study was covered acid hydrolysis, base hydrolysis, peroxide, photolytic (UV light) and thermal degradation was performed to prove the specificity of the proposed method and degradation was achieved. The developed method has been statistically validated according to ICH guidelines and found to be simple, precise, linear and accurate with the prescribed values. Thus the proposed RP-HPLC method was successfully applied for the substance in routine quality control analysis in active pharmaceutical ingredients.
Mitali Manjrawala *, Srinivasarao VN Divvela and Rakesh Kumar
Department of chemistry, Shri Jagdishprasad Jhabarmal Tibrewal University, Jhunjhunu, Churela, Rajasthan, India.
07 September 2020
04 February 2021
08 July 2021
01 September 2021