RESEARCH ON METHOD DEVELOPMENT AND VALIDATION OF
DECLATASVIR DIHYDROCHLORIDE BY RP HPLC METHOD
Miss. Trupti M.Haral
, Miss. Monali moreshwar Sawarbandhe , Mr. Prajyot Balu Ravat , Miss. Dipika Jagdish Joshi , Miss.Warad Tanuja Annarao
Daclatasvir, Dihydrochloride , UV, HPLC, Method validation.
Daclatasvir HCl is an antiviral drug. Daclatasvir dihydrochloride is the most frequently used as antiviral drug for a treatment of hepatitis C virus. Daclatasvir HCl prevents RNA replication and virion assembly by binding to NS5A, a nonstructural phosphor protein encoded by HCV Daclatasvir HCl efficient in vitro against viral strains less sensitive to other PIs. Present investigation involves the development and validation of chromatographic method for Daclatasvir HCl in bulk drug as well as pharmaceutical dosage form as per ICH guideline. The spectrophotometric determination was performed in UV Shimadzo, Model: UV-1800. The separation was conducted by Methanol. The wavelength was found at wavelength 315 nm. Chromatographic determination was performed on Agilent 1220 Infinity LC with ezchrome software with variable wavelength detector. The separation was conducted by using Zobrax Eclipse XDB-C 18 (4.6×150×5µm) with mobile phase consisting of acetonitrile: methanol: water in the ratio (60:30:10). The mobile phase was delivered at the flow rate of 1.0 ml/min. The eluent was monitored at wavelength 315 nm by variable wavelength detector and found a sharp and symmetrical peak with retention time 3.5.The method was validated for linearity, accuracy, precision, system suitability, and stability. The method was found to be linear over the concentration range 2-12µg/ml with coefficient regression R2 -0.999.The obtained results proved the method can be employed for the routine analysis of Daclatasvir HCl in bulk drug as well as in a commercial formulations.
"RESEARCH ON METHOD DEVELOPMENT AND VALIDATION OF
DECLATASVIR DIHYDROCHLORIDE BY RP HPLC METHOD", IJNRD - INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT (www.IJNRD.org), ISSN:2456-4184, Vol.9, Issue 10, page no.a770-a797, October-2024, Available :https://ijnrd.org/papers/IJNRD2410082.pdf
Volume 9
Issue 10,
October-2024
Pages : a770-a797
Paper Reg. ID: IJNRD_301110
Published Paper Id: IJNRD2410082
Downloads: 00049
Research Area: Pharmacy All
Country: Anjanvihire, MAHARASHTRA, India
ISSN: 2456-4184 | IMPACT FACTOR: 8.76 Calculated By Google Scholar | ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.76 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator
Publisher: IJNRD (IJ Publication) Janvi Wave
