A QBD APPROACH FOR HPLC METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION STUDIES OF RILPIVIRINE

Registration ID: IJNRD_327991

Published ID: IJNRD2608278

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Eefa Karbelkar, Kanchan Chauhan

HPLC, Method development, Method validation, Forced degradation, ICH guidelines, Design of Experiment.

The present study set out to create and validate a reliable and precise HPLC method for estimating Rilpivirine, employing a systematic Quality by Design (QbD) approach. We optimized key method parameters, including flow rate and mobile phase composition, through risk assessment and Central Composite Design (CCD). The final chromatographic conditions featured a C18 column, a mobile phase made up of phosphate buffer (pH 3.6) and acetonitrile in a 40:60 v/v ratio, a flow rate of 1.0 mL/min, UV detection at 298 nm. Under these settings, Rilpivirine exhibited a retention time of 3.3 minutes with excellent peak symmetry. We validated the method in accordance with ICH Q2(R2) guidelines, achieving remarkable linearity across a concentration range of 10–50 ppm, with an R² value of 0.9973. Accuracy tests revealed recoveries ranging from 98.88% to 108.15%, while precision assessments yielded %RSD values below 1%, confirming the method's reliability. The limits of detection (LOD) and quantification (LOQ) were determined to be 2.97 μg/mL and 9 μg/mL, respectively. Forced degradation studies conducted under acidic, alkaline, oxidative, thermal, and photolytic conditions indicated degradations of 13.04%, 19.87%, 18.2%, 19.7%, and 15.2%, respectively. These findings validated that the developed method could effectively separate Rilpivirine from its degradation products, highlighting its stability-indicating capabilities. The HPLC method proved to be precise, cost-effective, and well-suited for routine quality control and stability assessments of Rilpivirine formulations.

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Eefa Karbelkar & Kanchan Chauhan (August-2026). A QBD APPROACH FOR HPLC METHOD DEVELOPMENT, VALIDATION AND FORCED DEGRADATION STUDIES OF RILPIVIRINE. INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 11(8), c775-c784. https://ijnrd.org/papers/IJNRD2608278.pdf

Volume 11 Issue 8, August-2026

Pages : c775-c784

Paper Reg. ID: IJNRD_327991

Published Paper Id: IJNRD2608278

Research Area: Health Science All

Author Type: Indian Author

Country: Mahad/ Raigad, Maharashtra, India

Published Paper PDF: https://ijnrd.org/papers/IJNRD2608278.pdf

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