Paper Title
Stability Indicating Method Development and Validation with a QbD Approach of Rifaximin and Pharmaceutical Dosage Form by RP-HPLC
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Stability Indicating Method Development and Validation with a QbD Approach of Rifaximin and Pharmaceutical Dosage Form by RP-HPLC
Abstract
A gradient reversed-phase high-performance liquid chromatographic (RP-HPLC) method was successfully developed and validated for the estimation of Rifaximin in bulk and pharmaceutical dosage forms. Separation was achieved using a Phenomenex C18 column with a mobile phase consisting of methanol and 0.1% ortho phosphoric acid (75:25 v/v), at a flow rate of 1.0 mL/min, and UV detection at 292 nm. The method demonstrated excellent linearity (10–50 μg/mL), with a correlation coefficient (R²) of 0.999. The limit of detection (LOD) and quantitation (LOQ) were found to be 0.081 μg/mL and 0.246 μg/mL, respectively. Forced degradation studies revealed Rifaximin's higher sensitivity to acidic conditions, while it was stable under alkaline, thermal, and photolytic environments. The developed method was validated as per ICH Q2(R1) guidelines and proved to be accurate, specific, precise, and robust. This study also implemented a Quality by Design (QbD) approach to method optimization, ensuring robust analytical performance and long-term applicability for routine quality control.
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How To Cite (APA)
Ms. Disha Chavhan & Prof. Pallavi Patharkar (August-2025). Stability Indicating Method Development and Validation with a QbD Approach of Rifaximin and Pharmaceutical Dosage Form by RP-HPLC. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 10(8), b88-b94. https://ijnrd.org/papers/IJNRD2508113.pdf
Issue
Volume 10 Issue 8, August-2025
Pages : b88-b94
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Paper Reg. ID: IJNRD_308773
Published Paper Id: IJNRD2508113
Downloads: 000121989
Research Area: Science and Technology
Author Type: Indian Author
Country: -, -, India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2508113.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2508113
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