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In the context of superficially porous silica particles: simultaneous determination of dutasteride and tamsulosin from biological samples

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Abstract

The aim of this study is to develop a selective liquid chromatographic method for the simultaneous determination of tamsulosin HCl and dutasteride which are used for prostate treatment, in the context of an analytical column that is packed with superficially porous particles. Therefore, compositions of the mobile phase were determined for the best separation of these compounds. For this reason, experimental conditions such as varied pH values of buffer solution, temperature of the column, additives, flow rate of mobile phase and different buffer solutions were optimized. As the final condition, Kinetex C 18 analytical column (150 × 4.6; 5 µm) (Phenomenex, USA) and an acetonitrile/water 60: 40 (v/v), 0.1% o-phosphoric acid (pH adjusted to 7.0 using 5 M with NaOH) as a mobile phase are used for the best chromatographic separation. The separation was carried out at 45 °C column temperature with detection at 220 nm, and rilpivirine was chosen as an internal standard. As a result, the proposed method under optimum conditions is easy of application, rapid, precise, sensitive, accurate and fully validated. Furthermore, there is no need for time-consuming sample preparation technique, and because of this reason, it can be applied to quality control laboratories simply. Also, the optimized method can be successfully applied for the in vitro biological samples.

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Acknowledgements

This work was produced from the MSc Dissertation of Bogac Bugra Barut (Ankara University, Health Sciences Institute). The authors would like to thank Kocak Farma Ilac, Kimya Sanayi A.S. and Nobel Ilac San. ve Tic. A.S. (Istanbul, Turkey) for chemical substances support.

Funding

The authors would like to thank Ankara University Scientific Research Projects Commission for financial support (Project No: 15L0237004).

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Correspondence to Bengi Uslu.

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Barut, B.B., Erkmen, C., Gumustas, A. et al. In the context of superficially porous silica particles: simultaneous determination of dutasteride and tamsulosin from biological samples. J IRAN CHEM SOC 17, 1457–1465 (2020). https://doi.org/10.1007/s13738-020-01871-9

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