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Development of Stability Indicating Assay Method for Separation and Identification of Degradation Products of Daclatasvir Dihydrochloride by LC-ESI-QTOF-MS/MS

Development of Stability Indicating Assay Method for Separation and Identification of Degradation... AbstractA simple stability indicating method was developed for the assay of daclatasvir dihydrochloride using the principles of high performance liquid chromatography. The drug was subjected to forced degradation. The drug was found to degrade in hydrolytic (acid, base and neutral) and oxidative conditions resulting in the formation of four degradation products (DP1 to DP4). The degradation products were well separated by using stationary phase of a Waters Symmetry C18 (150 x 4.6 mm, 5 μm) column with mobile phase consisting of 10 mM ammonium acetate (pH 5.0) and acetonitrile in gradient elution. Subsequently the degradation products were identified by an online LC-ESI-QTOF-MS/MS. The chemical structures were proposed with the support of mass fragmentation and accurate mass data. The developed analytical method was validated as per ICH Q2 (R1) guidelines. The proposed analytical method is very useful for the determination of daclatasvir and its degradation products in bulk drug or formulations thereby demonstrating its stability indicating potential. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Development of Stability Indicating Assay Method for Separation and Identification of Degradation Products of Daclatasvir Dihydrochloride by LC-ESI-QTOF-MS/MS

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Development of Stability Indicating Assay Method for Separation and Identification of Degradation Products of Daclatasvir Dihydrochloride by LC-ESI-QTOF-MS/MS

Abstract

AbstractA simple stability indicating method was developed for the assay of daclatasvir dihydrochloride using the principles of high performance liquid chromatography. The drug was subjected to forced degradation. The drug was found to degrade in hydrolytic (acid, base and neutral) and oxidative conditions resulting in the formation of four degradation products (DP1 to DP4). The degradation products were well separated by using stationary phase of a Waters Symmetry C18 (150 x 4.6 mm, 5 μm)...
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Publisher
Taylor & Francis
Copyright
© 2019 Har Krishan Bhalla & Sons
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2019.1614090
Publisher site
See Article on Publisher Site

Abstract

AbstractA simple stability indicating method was developed for the assay of daclatasvir dihydrochloride using the principles of high performance liquid chromatography. The drug was subjected to forced degradation. The drug was found to degrade in hydrolytic (acid, base and neutral) and oxidative conditions resulting in the formation of four degradation products (DP1 to DP4). The degradation products were well separated by using stationary phase of a Waters Symmetry C18 (150 x 4.6 mm, 5 μm) column with mobile phase consisting of 10 mM ammonium acetate (pH 5.0) and acetonitrile in gradient elution. Subsequently the degradation products were identified by an online LC-ESI-QTOF-MS/MS. The chemical structures were proposed with the support of mass fragmentation and accurate mass data. The developed analytical method was validated as per ICH Q2 (R1) guidelines. The proposed analytical method is very useful for the determination of daclatasvir and its degradation products in bulk drug or formulations thereby demonstrating its stability indicating potential.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: Mar 4, 2019

Keywords: Daclatasvir dihydrochloride; stability indicating assay method; forced degradation; LC-ESI-QTOF-MS/MS

References

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  • Development and Validation of Rapid Stability-Indicating RP-HPLC-DAD Method for the Quantification of Lapatinib and Mass Spectrometry Analysis of Degraded Products
  • Stability-Indicating HPLC-DAD Method for the Determination of Linagliptin in Tablet Dosage Form: Application to Degradation Kinetics
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  • A Stability-Indicating UPLC Method for the Determination of Potential Impurities and Its Mass by a New QDa Mass Detector in Daclatasvir Drug Used to Treat Hepatitis C Infection
  • Development and validation of stability indicating RP-HPLC method for the estimation of Daclatasvir in bulk and formulation
  • Stability Indicating HPLC Method Development and Validation for Determination of Daclatasvir in Pure and Tablets Dosage Forms
  • Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of sofosbuvir and daclatasvir dihydrochloride in solid dosage form
  • Reversed- Phase Liquid Chromatographic Method for Determination of Daclatasvir Dihydrochloride and Study of Its Degradation Behaviour
  • Development of Stability Indicating HPLC-UV Method for Determination of Daclatasvir and Characterization of Forced Degradation Products