EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE  , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , IP Indexing (IP Value 2.40) , Web of Science Group (Under Process) , Directory of Research Journals Indexing , 

 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

METHOD DEVELOPMENT AND VALIDATION OF UV-VISIBLE SPECTROSCOPIC METHOD FOR THE ESTIMATION OF ASSAY OF ANTI CANCER DRUGS- AXITINIB, BOSUTINIB, ERLOTINIB HYDROCHLORIDE, GEFITINIB AND PEMETREXED DISODIUM DRUGS IN API FORM.

V. Ashok Chakravarthy* and B. B. V. Sailaja

ABSTRACT

The objective of the present work is to develop a simple, efficient and reproducible spectrophotometric method for the quantitative estimation of Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib and Pemetrexed Disodium drugs in its active pharmaceutical ingredient (API) form. The developed UV-Visible spectrophotometric method for the quantitative estimation of drugs – Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib and Pemetrexed Disodium is based on measurement of absorption at a wavelength maximum (λmax) of 336nm, 269nm, 247nm, 250nm and 225nm using dimethylsulphoxide (DMSO) and methanol as diluents. The method was validated in terms of specificity, precision, linearity, accuracy, and robustness as per the ICH guidelines. The method was found to be linear in the range of 32% to 200% for Bosutinib and Erlotinib hydrochloride drug substances; 40% to 140% for Pemetrexed Disodium drug substance; 50% to 150% for Axitinib and Gefitinib drug substances. The percentage recovery values were in the range of 98.4 to 100.4% for Axitinib, 98.5 to 100.1% for Bosutinib, 99.7 to 100.4% for Erlotinib hydrochloride, 99.7 to 100.5% for Gefitinib and in the range of 99.8 to 100.5% for Pemetrexed Disodium at different concentration levels. Relative standard deviation for precision and intermediate precision results were found to be less than 2%. The correlation co-efficient value observed for linearity of Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib and Pemetrexed Disodium drug substances was not less than 0.99 for their respective drugs. Results obtained from the validation experiments prove that the developed method is quantified for the estimation of assay of Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib and Pemetrexed Disodium drug substances. The developed method can be successfully applied for routine analysis, quality control analysis and also suitable for stability analysis of assay of Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib and Pemetrexed Disodium in API form as per the regulatory requirements.

Keywords: Axitinib, Bosutinib, Erlotinib hydrochloride, Gefitinib, Pemetrexed Disodium, Method Development, Validation, UV-Visible spectrophotometry.


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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing