Development and Validation of Stability Indicating RP-HPLC Method for Quantitative Estimation of Enzalutamide in Enzalutamide Capsules Dosage Form

Objectives: A precise, accurate and selective stability-indicating reverse phase high performance liquid chromatographic assay method has been developed for the quantitative estimation of Enzalutamide in capsules dosage form. Materials Methods: The separation was achieved by using a stationary Waters X-Bridge Shield RP18 (150 x 4.6 mm, 3.5μ) mobile consisted perchloric acid buffer acetonitrile proportion (20:80 volume/volume). run velocity 1.2 mL/min. identified UV detector at wavelength 210 nm. Column oven temperature 25°C sample cooler infused quantity 20 μL, time 15 min. Results: As there is no meddling flanked blank placebo retention Enzalutamide. Degradation study results were shown significant degradation observed oxidation (peroxide) stress condition. Hence it can be concluded that sensitive to oxidation. To obtain system precision, conducted with six replicate injections. %RSD estimated from peak areas establish 0.55% correspondingly. relative standard deviation exactitude 0.55%. suggested HPLC technique linear over range 100.6-301.8 μg/mL, correlation coefficient 0.9999. accuracy studies as % recovery 50% to150% level. limit recovered revealed assortment 98 102% consequences obtained within limits. accurate. solution steadiness samples are stable upto 48 hr on bench top refrigerator (2-8°C). robust changes like flow rate column temperature. Performed filter validation 0.45 μm PVDF Nylon filterers suitable filtration. validated per ICH guidelines all parameters satisfy Q2 specification acceptance Conclusion: an accuracy, linearity, specificity, suitability, stability robustness. criteria. So, urbanized simple, cost-effective, eco-friendly, safe successfully employed routine analysis bulk pharmaceutical forms.