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Indian Journal of Pharmaceutical Education and ResearchNOW IN
Article

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

K Purvini1, Chethan IA2, Jaishree Vaijanathappa2★★ Corresponding author

  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

Jaishree Vaijanathappa

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; Revised: 02-12-2020; Accepted: 13-04-2021.

Volume 55, Issue 2S · pp. s589–s594 · PUBLISHED 2021 · DOI: 10.5530/ijper.55.2s.131

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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