EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

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 , Scholar Article Journal Index (SAJI) , International Scientific Indexing ( ISI ) , Scope Database , Academia ,

ISSN 2394-3211

Impact Factor: 7.065

ICV - 79.57

Abstract

DEVELOPMENT OF ANALYTICAL METHOD FOR THE DETERMINATION OF DAPAGLIFLOZIN IN BULK DRUG AND ITS PHARMACEUTICAL FORMULATION

Dr. R. Xavier Arulappa*, M. Jerubin Welsingh, E. Ebin Blesso, N. A. Nijil, M. Sangeetha, D. Swinton and Dr. G. R. Prasobh

ABSTRACT

Analytical method development and validation is important in development of Pharmaceutical preparations. The aim of the present work was to develop and validate a simple UV spectroscopic method for the determination of dapagliflozin in pharmaceutical dosage form. The UV spectrum of dapagliflozin in methanol showed λ max at 225nm. Beer's law obeyed in the concentration range of 5- 25µg / ml. This method was carried out according to ICH Q2R1 guidelines by taking the parameters for linearity, accuracy, precision, ruggedness and robustness. The method was rugged and robustness with % relative standard deviation less than 2. The extraction recoveries was found to be higher than 99% in all experimental conditions. Based upon the performance characteristics the proposed method was found accurate, precise and rapid and suitable for the determination of dapagliflozin for routine analysis.

Keywords: Dapagliflozin, UV spectrophotometry, Method development, Validation.

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