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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.

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.

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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