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Novel Analytical Method Development, Validation and Stability Study of Anticancer Drug Erlotinib in Tablet Dosage Form by RP-UFLC

1, 2, 2

  1. 1Department of Pharmaceutical Analysis, Sri Adichunchanagiri College of Pharmacy, B. G. Nagara, Karnataka, INDIA.
  2. 2Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS AHER, Mysuru, Karnataka, INDIA.

CORRESPONDENCE

Dr. Jaishree V

Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS AHER, Mysuru-570015, Karnataka, INDIA.

vjaishree@jssuni.edu.in

Received: 29-05-2020; Accepted: 13-04-2021.

Volume 55, Issue 2s (Supplement) · pp. s589-s594 · 2021 · DOI: 10.5530/ijper.55.2s.131

ABSTRACT

Present work is aimed to develop a novel, simple and accurate reverse phase-ultrafast liquid chromatographic (RP-UFLC) method for erlotinib (ELB) in tablet dosage form. The chromatogram was achieved by using Eclipse plus C18 column with methanol and water along with triethylamine (TEA 0.1%) as mobile phase (50:50 v/v) at a flow rate of 1 ml/min. The tablet dosage form was assayed, validated and subjected to degradation studies. The standard ELB possessed a retention time of 5.51 min and the developed method was linear in the concentration range of 10-100 µg/ml with r2≤0.99. Validation parameters have shown that the developed method was precise (%RSD < 1), accurate (recovery 98.50 to 99.52%) and robust. In the degradation studies, no extra products were observed in thermal conditions and a degraded product was observed in negligible percentage in basic and acidic conditions.

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    Purvini, K., IA, C., & Vaijanathappa, J. (2021). Novel Analytical Method Development, Validation and Stability Study of Anticancer Drug Erlotinib in Tablet Dosage Form by RP-UFLC. Indian Journal of Pharmaceutical Education and Research, 55(2s), s589-s594. https://doi.org/10.5530/ijper.55.2s.131

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    © 2021 Author(s)

    This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited. CC BY 4.0