A new analytical RP-HPLC method development and validation for the estimation of Nilutamide in bulk form and marketed pharmaceutical dosage form
Department of Pharmaceutical Analysis, Dhanvanthri College of Pharmaceutical Sciences, Thirumala Hills, Centre City, Appannapally, Mahabubnagar, Telangana 509001, India.
Research Article
World Journal of Advanced Research and Reviews, 2024, 23(01), 2413–2424
Publication history:
Received on 12 June 2024; revised on 20 July 2024; accepted on 23 July 2024
Abstract:
A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Nilutamide, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 150 mm, 5 µm) column using a mixture of Methanol and water (45: 55 % v/v) as the mobile phase at a flow rate of 0.8 ml/min, the detection was carried out at 260 nm. The retention time of the Nilutamide was 2.379 ± 0.02 min respectively. The method produce linear responses in the concentration range of 24-120 mg/ml of Nilutamide. The method precision for the determination of assay was below 2.0 % RSD. The method is useful in the quality control of bulk and pharmaceutical formulations. The method was validated for accuracy, precision, linearity, robustness, ruggedness and LOD & LOQ of standard solution. The developed RP-HPLC method was found to be accurate, precise, linear, and robust and was successful applied to a pharmaceutical tablet formulation for qualitative estimation of Nilutamide in Bulk form and Marketed Pharmaceutical Dosage forms.
Keywords:
Nilutamide; RP-HPLC; Method Development; Validation; Accuracy
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