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This is a Experimental Study study.

September 28, 2025

A New Stability Indicating RP-HPLC Method for the Estimation of Bicalutamide

Key Points

The new RP-HPLC method shows high linearity with an R² value of 0.9999 over a concentration range of 0.1-120mg/ml.
Validation was based on ICH guidelines, ensuring the method's reliability through stress degradation studies.
The method achieved a limit of quantitation of 0.0919mg/ml and a limit of detection of 0.0301mg/ml, confirming sensitivity.
Optimized mobile phases included phosphate buffer and a mixture of Acetonitrile, Methanol, and Water for effective chromatographic performance.

Abstract

Bicalutamide is an anti-cancer drug used for metastatic prostate cancer treatment. A new stability indicating RP-HPLC method was developed and validated for the determination of Bicalutamide in tablets. Shimadzu HPLC Model no. iSeries 2050C 3D with Lab solutions Software with PDA detector and Inertsil C8 column (150 x 4.6 mm., 5mm) were used for the present study. Phosphate buffer (pH adjusted to 2.90 using ortho phosphoric acid) was used as mobile phase A and a mixture of Acetonitrile: Methanol: Water (80: 10: 10, v/v) was used as mobile phase B with flow rate 1.3 mL/min were the optimised chromatographic conditions (Detection wavelength 270 nm). The method was linear over the concentration range 0.1-120mg/ml with linear regression equation, y = 20351x + 980.75 (R² = 0.9999). The LOQ and LOD were found to be 0.0919mg/ml and 0.0301 respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines.

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