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Published on:June 2021
Indian Journal of Pharmaceutical Education and Research, 2021; 55(2s):s589-s594
Analysis | doi:10.5530/ijper.55.2s.131

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

Authors and affiliation (s):

Purvini K,1 Chethan IA,2 Jaishree Vaijanathappa,2,*

1Department of Pharmaceutical Analysis, Sri Adichunchanagiri College of Pharmacy, B. G. Nagara, Karnataka, INDIA.

2Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS AHER, Mysuru, Karnataka, INDIA.


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.

Key words: Erlotinib, Accuracy, Precision, Robustness, Degradation study.



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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.


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