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

Ashu MİTTAL; Alankar SHRİVASTAVA

doi:https://doi.org/10.52794/hujpharm.895556

Makale detayları

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

Yazarlar:

Ashu MİTTAL | Alankar SHRİVASTAVA

Yayıncı:

Hacettepe University

Ana Başlıklar:

Farmakoloji ve terapötik

Dergi:

Hacettepe University Journal of the Faculty of Pharmacy 2021 Vol.41 Issue 2, pp.82-92

Belge Tipi:

Makale

Yayın Tarihi:

5/2021

Belge Dili:

İngilizce

Document ID (Org No.):

2000454290

Sıklık:

Üç Aylık

eISSN:

2458-8806

DOI:

https://doi.org/10.52794/hujpharm.895556

Özet:

 

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.

 

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.

Makale detayları

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

Yazarlar: Ashu MİTTAL | Alankar SHRİVASTAVA

Yayıncı: Hacettepe University

Ana Başlıklar: Farmakoloji ve terapötik

Dergi: Hacettepe University Journal of the Faculty of Pharmacy 2021 Vol.41 Issue 2, pp.82-92

Belge Tipi: Makale

Yayın Tarihi: 5/2021

Belge Dili: İngilizce

Document ID (Org No.): 2000454290

Sıklık: Üç Aylık

eISSN: 2458-8806

DOI: https://doi.org/10.52794/hujpharm.895556

Sayı

Yazarlar:

Ashu MİTTAL | Alankar SHRİVASTAVA

Yayıncı:

Hacettepe University

Ana Başlıklar:

Farmakoloji ve terapötik

Dergi:

Hacettepe University Journal of the Faculty of Pharmacy 2021 Vol.41 Issue 2, pp.82-92

Belge Tipi:

Makale

Yayın Tarihi:

5/2021

Belge Dili:

İngilizce

Document ID (Org No.):

2000454290

Sıklık:

Üç Aylık

eISSN:

2458-8806

DOI:

https://doi.org/10.52794/hujpharm.895556