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

  • K Purvini1Department of Pharmaceutical Analysis, Sri Adichunchanagiri College of Pharmacy, B. G. Nagara, Karnataka, INDIA.
  • Chethan IA2Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS AHER, Mysuru, Karnataka, INDIA.
  • Jaishree Vaijanathappa2Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS AHER, Mysuru, Karnataka, INDIA.

Volume 55 Issue 2s Pages s589-s594

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.

Keywords

  • Erlotinib
  • Accuracy
  • Precision
  • Robustness
  • Degradation study
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