A new stability indicating RP-HPLC method for estimation of Osimertinib Mesylate

  • Talluri Chakradhar Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India
  • Sumanta Mondal Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India
  • Goutham Kumar Vanapalli Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

Abstract

A simple stability-indicating high-performance liquid chromatographic method was developed and validated for the determination of Osimertinib Mesylate in tablet dosage forms. Reversed-phase chromatography was performed on Shimadzu Model CBM-20A/20 Alite, using a mixture of 0.1% T.E.A and methanol (50:50, v/v) as mobile phase with a flow rate of 1.0 mL/min.  Detection was carried at 211nm. Linearity was observed over the concentration range of 10–400 μg/mL (R2 = 0.9992) with regression equation y = 125927x + 192648 Osimertinib Mesylate was subjected to stress conditions (acidic, alkaline, oxidation and thermal degradation) and validated as per ICH guidelines. The validated method can be applied to perform long-term and accelerated stability studies of Osimertinib Mesylate formulations.

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Author Biographies

Talluri Chakradhar, Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

Sumanta Mondal, Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

Goutham Kumar Vanapalli, Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam-530045, India

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1.
Chakradhar T, Mondal S, Vanapalli GK. A new stability indicating RP-HPLC method for estimation of Osimertinib Mesylate. JDDT [Internet]. 15Apr.2019 [cited 1Jun.2020];9(2-s):391-5. Available from: http://jddtonline.info/index.php/jddt/article/view/2733