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Research Journal of Pharmacy and Technology
Year : 2019, Volume : 12, Issue : 7
First page : ( 3437) Last page : ( 3443)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2019.00582.1

Stability indicating LC-TQ-ESI-MS method for the quantification of Racecadotril in presence of its degradants

Pradhan Debi Prasad*, Annapurna Mukthinuthalapati Mathrusri

Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh-530045, India

*Corresponding Author E-mail: debi.rips@gmail.com

Online published on 24 December, 2019.

Abstract

Racecadotril is an anti-diarrheal drug. Waters Alliance e2695 with PDA detector (2998) Zorbax SB C18 column (150 x 4.6 mm, 3.5 μm) (Isocratic mode) was used for the quantification of Racecadotril. A mixture of water and Acetonitrile (50:50) was used as diluent and the injection volume was 20 μl. The flow rate was 1.0mL/min (Detection wave length 230 nm). Linearity was evaluated in the concentration range 1–360 μg/ml with regression equation y = 14710 x+9958.9(Correlation coefficient R2 = 0.9996). The LOD and LOQ were found to be 0.2942 μg/mL and 0.9694 μg/mL respectively. Forced degradation studies were conducted for Racecadotril capsules and method validation was performed as per ICH guidelines.

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Keywords

Racecadotril, LC-TQ-MS, Forced degradation studies, validation, ICH guidelines.

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