This study aimed to develop and validate a stability-indicating reverse-phase high-
performance liquid chromatography (RP-HPLC) method for the quantification of Rilpivirine in its
formulations. The analysis was performed using an HPLC system (Waters - Alliance 510)
equipped with UV-484 detector and controlled by Data Ace software (Instrument I.D: AL-011).
A hypersil BDS C18 analytical column (250 X 4.6 mm X 5) was employed. A novel mobile phase
composed of buffer and acetonitrile in a 20:80 (V/V) ratio was utilized at a flow rate of 1.2 ml/min.
Detection was conducted at 300 nm. The stability-indicating nature of the method was evaluated
through stress testing, including hydrolytic degradation under acidic, basic, and neutral conditions,
UV degradation, and thermal degradation. The method exhibited a linear relationship over the concentration range of 12.50-37.50 ppm, described by the regression equation y = 21.58x + 135.1
(r2 = 0.999). The limits of detection (LOD) and quantification (LOQ) were found to be 0.2 and 0.6
g/ml, respectively. Rilpivirine demonstrated exceptional stability under conditions of heat,
oxidative stress, acidity, basicity and neutrality. The developed method was validated for
robustness, linearity, specificity, accuracy, and precision. It displayed excellent specificity,
accuracy, speed, precision, reliability, and reproducibility, making it suitable for the analysis of
commercial dosage forms as recommended by ICH guidelines.
Keywords: Forced Degradation Studies, ICH Guidelines, Rilpivirine, RP-HPLC, Stability Studies
Publication date: 01/01/2025
https://ijbpas.com/pdf/2025/January/MS_IJBPAS_2025_8625.pdf
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https://doi.org/10.31032/IJBPAS/2025/14.1.8625
