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Paper Title

RESEARCH ON METHOD DEVELOPMENT AND VALIDATION OF DECLATASVIR DIHYDROCHLORIDE BY RP HPLC METHOD

Article Identifiers

Registration ID: IJNRD_301110

Published ID: IJNRD2410082

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Keywords

Daclatasvir, Dihydrochloride , UV, HPLC, Method validation.

Abstract

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.

How To Cite (APA)

Miss. Trupti M.Haral, Miss. Monali moreshwar Sawarbandhe, Mr. Prajyot Balu Ravat, Miss. Dipika Jagdish Joshi, & Miss.Warad Tanuja Annarao (October-2024). RESEARCH ON METHOD DEVELOPMENT AND VALIDATION OF DECLATASVIR DIHYDROCHLORIDE BY RP HPLC METHOD. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 9(10), a770-a797. https://ijnrd.org/papers/IJNRD2410082.pdf

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Other Publication Details

Paper Reg. ID: IJNRD_301110

Published Paper Id: IJNRD2410082

Downloads: 000122030

Research Area: Pharmacy All

Author Type: Indian Author

Country: Anjanvihire, MAHARASHTRA, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2410082.pdf

Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2410082

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Journal Name: INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT(IJNRD)

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Call For Paper - Volume 10 | Issue 11 | November 2025

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