Separation of Four Impurities and Degradants by LC: A Case of Bicalutamide

Abstract

Bicalutamide is an antiandrogen preparation primarily indicated for the treatment of treat prostate carcinoma. Although several analytical methods have been described, a liquid chromatography method determination in the presence of impurities (Impurity A, B, C and BIC-2) and degradation products is still unexamined. Thus, a simple chromatography method is illustrated for bicalutamide in the presence of impurities and degradation products under stress conditions. The separation method is reverse phase, with octyl column on Agilent HPLC 1100 series equipment. The mobile phase was combination of phosphate buffer and acetonitrile. The developed method was validated according to International Conference on Harmonisation Guidelines. Bicalutamide and its four process related impurities and degradants were successfully separated by using proposed method. The method was found to be linear between 70 to 130 µg/ml, the regression equation y = 19.647x + 18.645 with correlation coefficient value of 0.9999. The method was found to be accurate and precise enough to be used for analysis. The LOD and LOQ values found were 0.031, 0.031, 0.031, 0.028, 0.029 µg/ml and 0.083, 0.083, 0.103, 0.075, 0.098 µg/ml for impurity A, B, C, BIC-2 and BCL respectively. The proposed analytical methodology is simple, robust, specific and accurate enough for routine analysis of bicalutamide API and its other four process related impurities and degradants.

Keywords

• Analytical methods
• Bicalutamide
• bicalutamide impurities
• method development
• analysis

Project Number

NA

Separation of Four Impurities and Degradants by LC: A Case of Bicalutamide

Abstract

Bicalutamide is an antiandrogen preparation primarily indicated for the treatment of treat prostate carcinoma. Although several analytical methods have been described, a liquid chromatography method determination in the presence of impurities (Impurity A, B, C and BIC-2) and degradation products is still unexamined. Thus, a simple chromatography method is illustrated for bicalutamide in the presence of impurities and degradation products under stress conditions. The separation method is reverse phase, with octyl column on Agilent HPLC 1100 series equipment. The mobile phase was combination of phosphate buffer and acetonitrile. The developed method was validated according to International Conference on Harmonisation Guidelines. Bicalutamide and its four process related impurities and degradants were successfully separated by using proposed method. The method was found to be linear between 70 to 130 µg/ml, the regression equation y = 19.647x + 18.645 with correlation coefficient value of 0.9999. The method was found to be accurate and precise enough to be used for analysis. The LOD and LOQ values found were 0.031, 0.031, 0.031, 0.028, 0.029 µg/ml and 0.083, 0.083, 0.103, 0.075, 0.098 µg/ml for impurity A, B, C, BIC-2 and BCL respectively. The proposed analytical methodology is simple, robust, specific and accurate enough for routine analysis of bicalutamide API and its other four process related impurities and degradants.

Keywords

• : Analytical methods
• Bicalutamide
• bicalutamide impurities
• method development
• analysis

Supporting Institution

NA

Project Number

NA

References

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