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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 8
First page : ( 3679) Last page : ( 3684)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00675.3

New Stability Indicating Liquid Chromatographic Method for the Quantification of Racecadotril (An Anti-Diarrheal Drug)

Kallepalli Pramadvara*, Annapurna Mukthinuthalapati Mathrusri

Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, India

*Corresponding Author E-mail: pramadvarakallepalli4@gmail.com

Online published on 31 October, 2018.

Abstract

A new sensitive and validated liquid chromatographic method has been proposed for the determination of Racecadotril in capsules. Waters model 2695 alliance HPLC system with Symmetry shield, RP-18, 250x 4.6mm, 5μ particle size and Waters 2996 Photodiode array detector was used for the chromatographic study of Racecadotril. Mobile phase mixture containing phosphate buffer: acetonitrile:trimethylamine (40:60: 0.1 v/v)adjusted to pH 4.0 withorthophosphoric acid) (flow rate 1 ml/min) (UV detection at 230 nm) was used. Linear regression equation was found to be y = 33904x + 25748 (R2 = 0.9997) with LOD and LOQ as 0.3925 and 1.2013 μg/mL respectively. Racecadotril was investigated for stability using acidic, oxidation, thermal, hydrolysis, photolytic (UV light and sunlight) and alkaline stress conditions. The proposed method for the quantification of Racecadotril in capsules was found to be selective and specific.

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Keywords

RP-HPLC, Racecadotril, stability-indicating, ICH guidelines, validation.

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