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Simple and Reliable Gas Chromatography Method for the Determination of 3-Quinuclidinol Content in Solifenacin Succinate Drug Substance

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1TitleTitle of DocumentSimple and Reliable Gas Chromatography Method for the Determination of 3-Quinuclidinol Content in Solifenacin Succinate Drug Substance
2CreatorAuthor's name, affiliation, country M. NARENDRA KUMARa*, V. KRISHNA REDDYb, HEMANT KUMAR SHARMAa, P. MADHAVA REDDYa, K.V.S.N. RAJUa, PRADEEP RAJPUTa and T. KALEEMULLAHa
aAurobindo Pharma Limited Research Centre-II, Survey No:71&72, Indrakaran Village, Sangareddy Mandal, Medak - 502 329, Andhra Pradesh, India
bDepartment of Chemistry, Sri Krishnadevaraya University, Anantapur - 515 003, Andhra Pradesh, India
3SubjectDicipline(s) Chemical Science
3SubjectKeywords Gas chromatography, Solifenacin succinate, 3-Quinuclidinol, Extraction, Validation
4DescriptionAbstract A simple and reliable gas chromatography method has been developed and validated for the determination of 3-quinuclidinol content in solifenacin succinate drug substance, using dimethyl-sulfoxide (DMSO) as internal standard (IS). Efficient chromatographic separation was achieved on DB-Wax, 15 m long with 0.53 mm i.d., 1.0 m particle diameter column consists with 100% polyethylene glycol as stationary phase including carrier gas as Helium. The analyte and internal standard were extracted in chloroform and monitored by flame ionization detector. The performance of the method was assessed by evaluating specificity, precision (repeatability, reproducibility), linearity, robustness and accuracy. No interference of organic solvents used in the synthesis was observed. The proposed method has a potential application to drug substances which may contains 3-quinuclidinol. The limits of detection (LOD) and limits of quantification (LOQ) established for 3-quinuclidinol, 40 g g-1 and 120 g g-1 respectively. The correlation coefficient value of linearity experiment is 0.9997. The average recovery for 3-quinuclidinol is 100.8%. The results proves that the validated method was suitable for determining 3-quinuclidinol content and method can be successfully applied for the routine analysis of solifenacin succinate drug substance.
5PublishersOrganizing agency, location WWW Publications, India
6Contributor Sponsor(s) -
7DateDate (YYYY-MM-DD) -
8TypeStatus & genre Peer-reviewed Article
8TypeType
9FormateFile Formate PDF
10IdentifierUniform Resource Identifier Click Here
10IdentifierDigital Object Identifier
11SourceJournal/conference title; vol., no. (Year)Chemical Science Transactions, Volume  1 , Number  (2), (2012)
12LanuguageEnglish=en en
13RelationSupp.files
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Chemical Science Transactions | Chem Sci Trans | CST | Online Chemistry Journal | Open Access
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