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.
Similar content being viewed by others
References
G. Amasya, M. Gumustas, U. Badilli, S.A. Ozkan, N. Tarimci, J. Pharmaceut. Biomed. 154, 285 (2018). https://doi.org/10.1016/j.jpba.2018.03.021
P. Siami, C.G. Roehrborn, J. Barkin, R. Damiao, M. Wyczolkowski, A. Duggan, K. Major-Walker, BB Morrill (2007) Contemp. Clin. Trials. 28(6), 770 (2007). https://doi.org/10.1016/j.cct.2007.07.008
J. Barkin, M. Guimarães, G. Jacobi, D. Pushkar, S. Taylor, OB Van Vierssen Trip (2003) Eur. Urol. 44(4), 461 (2003). https://doi.org/10.1016/S0302-2838(03)00367-1
M. Marberger, Nat. Clin. Pract. Urol. 3, 495 (2006)
P. Giriraj, T. Sivakkumar, Arab. J. Chem. 10, S1862 (2017). https://doi.org/10.1016/j.arabjc.2013.07.013
K. Ichioka, H. Ohara, N. Terada, Y. Matsui, K. Yoshimura, A. Terai, Y Arai (2004) Int. J. Urol. 11(10), 870 (2004). https://doi.org/10.1111/j.1442-2042.2004.00913.x
L.R. Snyder, J.J. Kirkland, J.W. Dolan, Introduction to Modern Liquid Chromatography, 3rd edn. (Wiley, New York, 2010)
S. Fekete, E. Oláh, J. Fekete, J. Chromatogr. A 1228, 57 (2012). https://doi.org/10.1016/j.chroma.2011.09.050
R. Hayes, A. Ahmed, T. Edge, H. Zhang, J. Chromatogr. A 1357, 36 (2014). https://doi.org/10.1016/j.chroma.2014.05.010
G. Guiochon, F. Gritti, J. Chromatogr. A 1218(15), 1915 (2011). https://doi.org/10.1016/j.chroma.2011.01.080
B. Siddartha, I Sudheer Babu, CR Gupta, C Parthiban (2014) Asian. J. Pharm. Clin. Res 7, 156 (2014)
S. Mhamunkar, R. Vyavaharkar, Int. J. Pharm. Pharm. Sci. 4, 319 (2014)
M. Kantor-Boruta, M. Lisowska-Kuźmicz, A. Jończyk, J. Siedlecka, A. Ocios-Bębenek, M. Jarończyk, A.P. Mazurek, H. Ksycińska, Z. Chilmonczyk, M. Jarosz, Talanta 10, 75 (2012). https://doi.org/10.1016/j.talanta.2012.06.004
H.P. Shah, A. Khandar, S. Deshpande, S. Bagade, Res. J. Pharm. Biol. Chem. Sci. 5, 801 (2014)
R. Upreti, N.Z.M. Homer, G. Naredo, D.F. Cobice, K.A. Hughes, L.H. Stewart, B.R. Walker, R. Andrew, J. Chromatogr. B. Analyt. Technol. Biomed. Life. Sci. 930, 121 (2013). https://doi.org/10.1016/j.jchromb.2013.04.020
R. Andrew, KA. Hughes, LH. Stewart, AMM. Faqehi, R. Upreti, G. Naredo, and NZM. Homer, Talanta 131, 728 (2014). https://doi.org/10.1016/j.talanta.2014.07.087
J. Mohammad, Y.-M. Li, M. El-Ahmad, K. Nakazato, G. Pettersson, S. Hjerten, Chirality 5, 464 (2014)
G.S.K. Reddy, S.A. Kumar, M. Debnath, and V.R.A.J. Kumar, Asian J. Pharm. Clin. Res. 7, 105 (2014)
D.A. Skoog, F.J. Holler, S.R. Crouch, Principle of Instrumental Analysis, 6th edn. (Brooks Cole, Boston, 2006)
M. Celebier, M. Nenni, I. Suslu, S. Altınoz, Der. Pharma. Chemica. 7(6), 168 (2015)
ICH Validation of analytical procedures: text and methodology Q2 (R1), in International Conference on Harmonization (2005)
Guidance for Industry Q1A (R2), Stability testing of new drug substances and products in International Conference on Harmonisation (2003)
A. Cavazzini, M. Catani, A. Felinger, in Liquid Chromatography, edited by S. Fanali, PR. Haddad, CF. Poole, and ML. Riekkola (Elsevier, Amsterdam, 2017)
C.T. Sengel-Turk, M. Gumustas, B. Uslu, and SA Ozkan, in Nano- and Microscale Drug Delivery Systems, edited by A. M. Grumezescu (Elsevier, Amsterdam, 2017)
L. Karadurmus, M. Gumustas, S. Kurbanoglu, B. Uslu, S.A. Ozkan, Turk. J. Chem. 42(5), 1408 (2018). https://doi.org/10.3906/kim-1712-9
S. Fanali, G. D’Orazio, T. Farkas, B. Chankvetadze, J. Chromatogr. A 1269, 136 (2012). https://doi.org/10.1016/j.chroma.2012.06.021
B.M. Ishaq, K.V. Prakash, G.K. Mohan, Der Pharma Chem. 6(3), 103 (2014)
G.S.K. Reddy, S.A. Kumar, M. Debnath, VRAJ Kumar (2014) Int. J. Pharm. Pharm. Sci. 6(3), 77 (2014)
P. Giriraj, T.S. Kumar, Int. J. Drug Dev. Res. 6(2), 36 (2014)
L.S. Reddy, S.L.N.P. Reddy, G.S. Reddy, Orient. J. Chem. 29(4), 1665 (2013)
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).
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
The authors have no conflicts of interest to declare.
Electronic supplementary material
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
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
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s13738-020-01871-9