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Development and Validation of Chiral HPLC Method for the Identification and Quantification of Enantiomer in Posaconazole Drug Substance

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1TitleTitle of DocumentDevelopment and Validation of Chiral HPLC Method for the Identification and Quantification of Enantiomer in Posaconazole Drug Substance
2CreatorAuthor's name, affiliation, country CHERUKURU NAGARAJU1,2,*, UTTAM KUMAR RAY1 and SIDDAIAH VIDAVALUR2
1APL Research Centre-II(A Division of Aurobindo Pharma Ltd), Survey No: 71 and 72, Indrakaran(V), Sangareddy (M), Medak Dist., Hyderabad-502 329, Telangana, India
2Department of Organic Chemistry and FDW, Andhra University, Visakhapatnam-530 003, Andhra Pradesh, India
3SubjectDicipline(s) Chemical Science
3SubjectKeywords HPLC, Chiral chromatography, Normal phase, Posaconazole, Validation
4DescriptionAbstract A simple and sensitive normal phase isocratic high performance liquid chromatographic method was developed for the determination of trace level enantiomer in posazonazole drug substance. The separation was achieved using chiral pack, IC, 250 x 4.6 mm, 5 ?m using mobile phase containing isopropyl alcohol, dichloro methane and diethyl amine (50:50:0.1 v/v/v). The flow rate was 0.6 mL/min and column temperature was 25 ?C. Enantiomer was detected using UV detector at the wave length 262 nm. The retention time was 18.5 min for enantiomer and 28 min is for posaconazole. The optimized method was validated to prove its performance characteristic by demonstrating selectivity, sensitivity (Limit of detection and Limit of quantification), linearity, precision and accuracy. The limit of detection and limit of quantification of ennatiomer was found to be 0.06 μg/mL and 0.2 μg/mL for 10 μL injection volume. The linearity of the method is found to be 0.2 μg/mL to 1.5 μg/mL. Relative standard deviation of system precision, method precision is found to be 0.3% and 0.44% respectively. The accuracy of the method is found to be 96.0% to 98.1%.
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  7 , Number  (3), (2018)
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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