Design, Characterization, Analytical HPLC Method Validation, and Stability Studies of Racecadotril Capsules

نویسندگان

چکیده

This study aims to develop, characterize and validate analytical method perform stability studies of Racecadotril capsules treat acute diarrhea. Six formulations 100mg Capsules were prepared with different excipients by varying their concentrations. The HPLC was validated on parameters recommended ICH Q2R guidelines, including specificity, accuracy recovery, precision, quantitation limit, detection range, linearity, robustness. Forced degradation performed as per the Stability Indicating Method under various stress conditions. Accelerated three batches best fit formulation guidelines. Among six Capsule, F6 a comparatively good dissolution profile 76.9% release in 60 minutes. system suitable % R.S.D. 0.619147%, within acceptance criteria. Furthermore, robustness lie percent after photolytic (sunlight for 6 hr.), oxidative (3% H2O2), acidic (0.1N HCl) necessary NaOH) found be 6.5%, 5.8%, 11.4%, 28.4%, respectively. product remains unchanged thermal stress. successfully Capsule

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ژورنال

عنوان ژورنال: Sindh University research journal

سال: 2021

ISSN: ['1813-1743']

DOI: https://doi.org/10.26692/surj.v53i04.4220