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Validated Stability Indicating HPLC Method for Estimation of Daclatasvir

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1TitleTitle of DocumentValidated Stability Indicating HPLC Method for Estimation of Daclatasvir
2CreatorAuthor's name, affiliation, country K. V. LALITHA1*, J. RAVEENDRA REDDY1 and N. DEVANNA2
1Division of Pharmaceutical Analysis and Quality Assurance, Raghavendra Institute of Pharmaceutical Education and Research (RIPER)-Autonomous Ananthapuramu-515172, Andhra Pradesh, India
2Jawaharlal Nehru Technological University- OTPRI, Ananthapuramu, Andhra Pradesh, India
3SubjectDicipline(s) Chemical Science
3SubjectKeywords Assay, High performance liquid chromatography, Reverse phase, Daclatasvir validation
4DescriptionAbstract For the determination of daclatasvir from formulation, a new, simple, specific, accurate and robust isocratic reversed-phase (RP) stability indicating high-performance liquid chromatographic (HPLC) method has been developed and validated. The liquid chromatographic separation isocratically accomplished by means of a portable acetonitrile, buffer (0.1% Octa sulphonic acid) (70:30). The analysis was carried out using at ambient temperature on Xterra C18 (4.6x150 mm, 5.0 μm) at flow rate of 1 mL/min and the UV detection at 237 nm. The method was validated for accuracy, precision, linearity, range, selectivity and robustness. The linearity of the proposed method was investigated in the range of 20 to 100 μg/mL (r2 = 0.999). The drug was subjected to oxidation, hydrolysis, heat and photolysis to apply stress conditions. The method provided good peak parameters with retention time of 2.398 min. Degradation products resulting from stress studies did not interfere with the detection of daclatasvir and the assay can thus be considered as stability-indicating HPLC method.
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  8 , Number  (4), (2019)
12LanuguageEnglish=en en
13RelationSupp.files
14Coverage -
15CopyrightCopyright and permissions
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