DEVELOPMENT AND VALIDATION OFSPECTROPHOTOMETRIC METHOD FOR ENZALUTAMIDE IN STANDARD AND DOSAGE FORM BY FIRST DERIVETIVE SPECTROPHOTOMETRIC METHOD Authors: Patel TR , KAMANI KR, RATHI SG, VAGHELA SS AND VAJA MD
ABSTRACT
A simple, rapid, accurate and economical First order UV-derivative spectrophotometric method
has been developed for estimation of Enzalutamide from bulk and pharmaceutical
formulation.The ?max of Enzalutamide in methanol was found to be 236nm.The same spectrum
was derivatized into first order derivative; showed maxima at 226 nm and minima at 258 nm.
The drug follows linearity in the concentration range 05-15µg/ml with correlation coefficient
value 0.9993. The proposed method was applied to pharmaceutical formulation and %
amount of drug estimated 101.12% 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 101.67%–102.40%.
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 indicate 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 costeffective quality-control tool for routine analysis of Enzalutamide in bulk and in pharmaceutical
dosage form.
Keywords: Enzalutamide; Validation; first order derivative UV, quantitative determination, methanol Publication date: 01/05/2022 https://ijbpas.com/pdf/2022/May/MS_IJBPAS_2022_6073.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2022/11.5.6073