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

Abstract

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