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 (Under Process) , 

 ISSN 2394-3211

Impact Factor: 4.897

 ICV - 79.57

Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF SOFOSBUVIR IN ITS SYNTHETIC MIXTURE

Sandesh R. Lodha*, Hema G. Kamalja, Rimpal R. Patel, Shailesh A. Shah, Pintu B Prajapati, Gajanan G. Kalyankar

ABSTRACT

A stability indicating HPTLC method was developed and validated for estimation of Sofosbuvir in its synthetic mixture. Chromatographic separation was performed on pre-coated silica gel 60F254 aluminum plates using the mobile phase Toluene: Acetone: Acetic Acid: Water (6.5:3.5:1:0.2v/v). The Rf value for Sofosbuvir was found to be 0.67. The spots were scanned densitometrically at 267 nm. The solvent system was able to separate Sofosbuvir and its degradation products formed under acidic, alkaline and oxidative condition. Developed HPTLC method was validated as per ICH Q2 (R1) guideline. The linear regression analysis data for the calibration plots showed a good linear relationship with R2 value of Sofosbuvir is 0.997 in the concentration range of 200-1000 ng/band for Sofosbuvir. Percent recovery of drug was found in the range of 98.40-101.76 % by developed method. Limit of detection and limit of quantitation was found to be 16.08 ng/band and 48.73 ng/band for Sofosbuvir respectively. The method was applied to estimate Sofosbuvir in its Synthetic mixture.

Keywords: .


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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 (Under Process)