Research Journal of Pharmacy and Technology

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Stability Indicating LC-TQ-ESI-MS Method for the Quantification of Racecadotril in Presence of its Degradants


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

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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.

Keywords

Racecadotril, LC-TQ-MS, Forced Degradation Studies, Validation, ICH Guidelines.
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  • Stability Indicating LC-TQ-ESI-MS Method for the Quantification of Racecadotril in Presence of its Degradants

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Authors

Debi Prasad Pradhan
Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh-530045, India
Mukthinuthalapati Mathrusri Annapurna
Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh-530045, India

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.

Keywords


Racecadotril, LC-TQ-MS, Forced Degradation Studies, Validation, ICH Guidelines.

References