ABSTRACT

A simple, rapid, accurate and economic stability indicating method has been developed for estimation of Enzalutamide from bulk and pharmaceutical formulation. In RP-HPLC method, chromatographic separation was achieved on Phenomenax, C18 (150mm×4.6mm×5m) column using Acetonitrile: Water (65:35 v/v) as the mobile phase with detection at 236 nm. The drug was subjected to acidic, alkali, oxidative, thermal and photolytic stress conditions whereas Capsule was subjected to thermal and photolytic stress conditions. The drug follows linearity in the concentration range 10-50 ?g/mL with correlation coefficient value 0.9995. The proposed method was applied to pharmaceutical formulation and % amount of drug estimated 101.09% was found in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels i.e., 80%, 100% and 120%. The % recovery was found to be in the range 99.45- 100.4%. The low values of %R.S.D. are indicative of the accuracy and reproducibility of the method. The precision of the method was studied as an intra-day, inter-day variations and repeatability. The %R.S.D. value less than 2 indicates that the method is precise. Ruggedness of the proposed method was studied with the help of two analysts. The above method was a rapid and cost- effective quality-control tool for routine analysis of Enzalutamide in bulk and in pharmaceutical dosage form. Keywords: Enzalutamide; Validation; Stability indicating, RP-HPLC, Quantitative determination, Methanol
Publication date: 01/07/2023

https://ijbpas.com/pdf/2023/July/MS_IJBPAS_2023_7276.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.7.7276