Chromatographic Methods for Determination of Finasteride and Tamsulosin Hydrochloride in Presence of Finasteride Degradation Product
March 2019
in “
Acta Chromatographica
”
Studysummary This study developed two sensitive chromatographic methods for determining finasteride and tamsulosin hydrochloride in pharmaceutical forms, validated against International Conference on Harmonisation guidelines. Our plain-language summary of this paper — not a Tressless recommendation.
The paper describes the development of two chromatographic methods for the determination of finasteride and tamsulosin hydrochloride in the presence of finasteride degradation product. The first method uses high-performance liquid chromatography (HPLC) separation of the drugs in the presence of the acid degradation product of finasteride, while the second method uses thin-layer chromatography (TLC)-densitometry. Both methods were validated according to International Conference on Harmonisation (ICH) guidelines. The study found that the HPLC method was more advantageous than a reported method, with better resolution, higher capacity, and greater sensitivity. The TLC method provided better separation for FIN and TAM.
