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

A VALIDATED STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF NATIGLINIDE IN BULK AND PHARMACEUTICAL DOSAGE FORMS

Challa Sudheer*, B. Tirumaleswara Rao, S. Madhavi and C. Rambabu*

ABSTRACT

A new simple, accurate, stability indicating RP-HPLC method has been developed and validated for assay of Nateglinide in pure and dosage forms. Chromatographic analysis of Nateglinide in the present assay was carried out isocratically with a mobile phase consisting of 0.02M ammonium dihydrogen phosphate buffer (pH-4.0) and acetonitrile in the ratio of 40:60v/v. The flow rate was 1.0ml/min. The effluent was monitored spectrophotometrically at a wavelength of 226nm at ambient temperature with a retention time of 4.189 min respectively. The proposed RP-HPLC method was validated according to ICH guidelines with respect to specificity, precision, linearity and accuracy. The drug substance (Nateglinide) was subjected to stress conditions of hydrolysis, photolysis degradation. The degradation of Nateglinide was observed under acid, base and photolyticstress conditions and was found to be stable in other stress conditions studied.the oxidative stress studies revealed that natiglinide(Rt=4.189 min) was not fully degraded and its degradation products were eluted separatly at different retention times respectively. The percentage RSD for precision and accuracy of the proposed method for Nateglinide was found to be less than 2%. The proposed RP-HPLC method was successfully applied for routine analysis of Nateglinide in tablet dosage form.

Keywords: Nateglinide, RP-HPLC, Validation.


[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 )