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 ) , 

 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

QUALITY BY DESIGN BASED HPLC ASSAY METHOD DEVELOPMENT AND VALIDATION OF LINAGLIPTIN IN TABLET DOSAGE FORM

Sneha R. Barapatre, Anvesha V. Ganorkar and Krishna R. Gupta*

ABSTRACT

The current work describes QbD based simple and precise reversed-phase HPLC method development for routine analysis of Linagliptin in bulk drug and pharmaceutical formulations. Chromatographic separation was achieved on a ACE C18 column using isocratic elution with mobile phase containing mixture of phosphate buffer pH 7.2 adjusted with OPA 1% solution and methanol in the ratio (70:30v/v), with flow rate 1.0 mL/min and UV detection at 292 nm. The optimization of chromatographic method was carried by Box-Behnken design. The experimental design for the Assay method development utilizes three factors such as Mobile Phase (X1), Flow Rate (X2), and pH (X3) while Assymetry (Y1), Theoretical Plates (Y2), and Retention time (Y3) were used as responses. The developed experimental design was statistically analysed using ANOVA, counter plots and response surface plots. The method was optimized through system suitability test, linearity and assay of Linagliptin. The method was validated as per ICH guidelines for Accuracy, Precision, Ruggedness, LOD and LOQ which showed that proposed method was simple, sensitive, and highly robust for routine analysis of the Linagliptin.

Keywords: Linagliptin, Box-Behnken design, ANOVA, HPLC.


[Full Text Article]

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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 Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI )