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Chromatographic methods for determination of finasteride and tamsulosin hydrochloride and in presence of finasteride degradation product

Monir Hany H., Ali Alshimaa M., Refat Rawnaa E., Abbas Samah S.

Acta Chromatographica

2020

Vol. 32, no. 2

95--101

Two sensitive and selective chromatographic methods were developed for determination of finasteride and tamsulosin hydrochloride in bulk powder and a pharmaceutical formulation. The first method was based on high-performance liquid chromatography (HPLC) separation of the cited drugs in the presence of the acid degradation product of finasteride. The separation was achieved using a C18 column (300 mm × 3.9 mm; 10-μm particle size) and a mobile phase consisting of 0.04 M ortho-phosphoric acid (pH 3.5 ± 0.2 adjusted with triethylamine) and acetonitrile (50:50, v/v). Quantification was achieved with ultraviolet (UV) detection at 215 nm. Linearity was in the range of 10.00–110.00 μg/mL and 2.00–44.00 μg/mL for finasteride and tamsulosin hydrochloride, respectively. Thin-layer chromatography (TLC)–densitometric method was achieved on an aluminum plates pre-coated with silica gel 60 F254 using toluene–ethanol–diethylamine (8:2:1.5, by volume) as eluent, and the RF values of tamsulosin hydrochloride and finasteride were 0.57 and 0.64, respectively. Quantification was achieved with UV detection at 250 nm for finasteride and 280 nm for tamsulosin hydrochloride. Linearity was in the range of 1.00–40.00 and 0.2.00–20.00 μg per spot for finasteride and tamsulosin hydrochloride, respectively. The results obtained were validated according to the International Conference on Harmonisation (ICH) guidelines. A statistical comparison between the obtained results and the results of a reported method was carried out.

Development and validation of a reversed-phase HPLC method for simultaneous determination of doxazosin mesylate and finasteride

Krotz D., Mengesha A. E.

Acta Chromatographica

2017

Vol. 29, no. 3

309--324

A reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous determination of doxazosin mesylate (DOX) and finasteride (FIN) in bulk powders and pharmaceutical formulations. The compounds were separated on a Pinnacle II C18 column (250 × 4.6 mm i.d.; particle size, 5 μm) with an isocratic mobile phase at a flow rate of 1.0 mL min−1. The mobile phase was a mixture of 25 mM ammonium acetate and acetonitrile in the ratio of 50:50 %v/v. The pH of the buffer was adjusted to 4.0 ± 0.05 with glacial acetic acid. The detection was performed at 230 nm. The total chromatographic analysis time per sample was 15 min with DOX and FIN eluting at 3.9 and 7.2 min, respectively. The accuracy, precision, specificity, linearity, and sensitivity of the method were validated according to the International Conference on Harmonization (ICH) guidelines. The calibration plots were linear (r2 > 0.999) over the concentration range 24.25–291.0 μg mL−1 and 122.5–1470.0 μg mL−1 for DOX and FIN, respectively. The method was used for the simultaneous determination of DOX and FIN in capsules.