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

STABILITY-INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SITAGLIPTIN PHOSPHATE IN TABLET DOSAGE FORM

Ganesh S. Sarowar, Padmanabh B. Deshpande*, Yogesh R.Gandhi, Janvi J. Bhatt

ABSTRACT

The present work describes a new simple, precise and selective stability- indicating high performance thin layer chromatographic (HPTLC) method for estimation of Sitagliptin Phosphate as bulk drug and in tablet dosage form. The chromatographic development was carried out on precoated silica gel 60 F254 aluminium plates using mixture of Toluene: Methanol (8:2, v/v) as mobile phase. Densitometric evaluation of band was carried out at 265 nm. The retention factor for Sitagliptin Phosphate was found to be 0.38 ± 0.006. The drug was subjected to stress condition of hydrolysis (acid, base), oxidation, photolysis and thermal degradation. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity (2000-12000 ng band-1.), precision (intra-day RSD 0.76-1.19 %, inter-day RSD 1.34-1.82 %), accuracy (99.54±0.58) and specificity according to ICH guidelines. The method has been successfully applied for the analysis of drug in pharmaceutical formulation. The % assay (Mean ± S.D.) was found to be 98.99 ± 1.48. The developed method can be used for checking the stability of Sitagliptin Phosphate in bulk drug and pharmaceutical dosage form.

Keywords: Sitagliptin, HPTLC, Forced degradation, Validation.


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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 ) Scope Database Academia