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)

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 ISSN 2394-3211

Impact Factor: 7.065

 ICV - 79.57

Abstract

DEVELOPMENT AND VALIDATION OF SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF PRANLUKAST HYDRATE IN ITS SYNTHETIC MIXTURE

Gajanan G. Kalyankar*, Priti. H. Vansiya, Kunjan B. Bodiwala, Sandesh R. Lodha, Pintu B. Prajapati, Shrikant V. Joshi

ABSTRACT

Accurate, precise and robust UV spectrophotometric method has been developed and validated for the estimation of Pranlukast Hydrate in its synthetic mixture. UV-spectrophometric determination was carried out at an absorbance maxima of 262 nm using ethanol as solvent. Developed method has been validated for linearity range, precision, accuracy, limit of detection, and limit of quantification as per ICH Q2(R1) guidelines. Linear regression analysis data for the calibration plots showed a good linear relationship with R2 of 0.9984 for Pranlukast hydrate in concentration range of 10-50 μg/ml. The intraday and interday precision of the method in terms of % RSD were found to be 0.66-1.21 % and 0.81-1.33 % respectively. LOD for Pranlukast hydrate was found to be 0.49μg/ml, while LOQ was found to be 1.51μg/ml. %Recovery of Pranlukast hydrate was found in range of 98-100.1 %. The method was applied to synthetic mixture for analysis of Pranlukast hydrate. The assay result was found to be in good agreement with amount of Pranlukast hydrate present in synthetic mixture.

Keywords: Pranlukast hydrate, Spectrophotometric Method, Synthetic Mixture, 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