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

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

Identyfikatory

DOI

10.1556/1326.2019.00577

• Języki publikacji: EN

Abstrakty

EN

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.

Słowa kluczowe

EN

finasteride; Tamsulosin hydrochloride; HPLC; TLC-densitometry

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2020
• Tom: Vol. 32, no. 2
• Strony: 95--101
• Opis fizyczny: Bibliogr. 19 poz., rys.

Twórcy

autor

Monir Hany H.

• Cairo University, Kasr El-Aini Street, 11562, Cairo, Egypt

autor

Ali Alshimaa M.

• National Organizations for Drug Control and Research, Wezaret El-Zeraa Street, Cairo, Egypt

autor

Refat Rawnaa E.

• National Organizations for Drug Control and Research, Wezaret El-Zeraa Street, Cairo, Egypt

autor

Abbas Samah S.

• Cairo University, Kasr El-Aini Street, 11562, Cairo, Egypt

Bibliografia

• [1.] Budavari S. The Merck index 14th Ed., Merk and Co. Inc., white house station, NJ 1996.
• [2.] Sweetman Ed. S. C. Martindale The Complete Drug Reference 35th ed., Pharmaceutical Press, The Royal Pharmaceutical Society, London 2005.
• [3.] Hardman, J. G.; Limbard, L. E.; Gilman, A. G. Goodman Gilman’s: The pharmacological Basis of Therapeutics 9th ed McGraw-Hill, NewYork, 2001.
• [4.] Keski Rahkonen, P.; Parssinen, O.; Leppanen, E.; Mauriala, T.; Lehtonen, M.; Auriola, S.; Determination of tamsulosin in human aqueous humor and serum by liquid chromatography electrospray ionization tandem mass spectrometry J. Pharm. Biomed. Anal. 2007, 43, 606–612.
• [5.] Din, L.; Li, L.; Tao, P.; Yang, J.; Zhang, Z.; Quantitation of tamsulosin in human plasma by liquid chromatography electrospray ionization mass spectrometry J. Chromatogar. B. 2002, 767, 75–81.
• [6.] Ramakrishna, N. V.; Vishwottam, K. N.; Manoj, S.; Koteshwara, M.; Wishu, S.; Varma, D. P.; Rapid, simple and highly sensitive LC-ESI-MS/MS method for the quantification of tamsulosin in human plasma Biomed. Chromatogr. 2005, 19, 709–719.
• [7.] Soeishi, Y.; Kobori, M.; Kobayashi, S.; Higuchi, S.; Sensitive method for the determination of tamsulosin in human plasma using high performance liquid chromatography with fluorescence detection J. Chromatogr. 1990, 533, 291–296.
• [8.] Sangita, A.;Veeran, K.; Amlan, S.; Debotri, G.; Uttam, B.; Tapas, C.; Tapan, P.; Simultaneous determination of tamsulosin and dutasteride in human plasma by LC-MS-MS, J. Chromatogr. 2008, 67, 893–903.
• [9.] Constanzer, M. L.; Chavez, C. M.; Matuszewski, B. K.; Picogram determination of finasteride in human plasma and semen by high performance liquid chromatography with atmospheric pressure chemical ionization tandem mass spectrometry J. Chromatogr. 1994, 658, 281–287.
• [10.] Guo, F. Q.; Huang, L. F.; Wong, K. P.; Dai, Y.H.; Li, Y. W.; Liang, Y. Z.; Huang, K. L.; Zhong, K. J.; Wu, M. J. A rapid, simple, specific liquid chromatographic electrospray mass spectrometry method for the determination of finasteride in human plasma and its application to pharmacokinetic study J. Pharm. Biomed. Anal. 2007, 43, 1507–1513.
• [11.] Xiaohong, C.; Erin, R. G.; Douglas, K. P.; William, D. F.; Development and validation of an LC-MS assay for finasteride and its application to prostate cancer prevention trial sample analysis J. Chromatogr. Sci. 2008, 46, 356–361.
• [12.] Ptacek, P.; Macek, J.; Klima, J.; Determination of finasteride in human plasma by liquid- liquid extraction and high performance liquid chromatography J. Chromatogr. 2000, 738, 305–310.
• [13.] Basavaiah, K.; Somashekar, B. C.; Determination of finasteride in tablets by high performance liquid chromatography E-J. Chem. 2007, 4, 109–116.
• [14.] Nasare, M. K.; Satish, J.; Amrohi, S. H.; Harshini, S.; Kumar, M.; Simultaneous determination of finasteride and tamsulosin in combined dosage form by using RP-HPLC method J. Liq. Chromatogr. Rel. Tech. 2014, 37, 1176–1186.
• [15.] Sindhura, M.; Raghavi, K.; Prashanthi, R.; Nalluri, B. N.; Simultaneous estimation of finasteride and tamsulosin hydrochloride in combined dosage form by using RP-HPLC-PDA method J. Appl. Pharm. Sci. 2012, 2, 203–209.
• [16.] The United States Pharmacopeia and National Formulary, USP 37-NF 32, U.S. Pharmacopeial Convention, Rockville, MD, 2014.
• [17.] Dash D. C. Analytical Chemistry New Delhi, India, 2011, p. 433.
• [18.] Hoffmann, E.; Stroobant, V. Mass Spectrometry: Principles and Application John Wiley &Son, 3rd edition, New York, USA, 2007.
• [19.] ICH, Q1A (R2), Stability Testing of New Drug Substances and Products, Q2 (R1) Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization, IFPMA, Geneva, Switzerland, (2003, 2005).

Uwagi

PL

Opracowanie rekordu ze środków MNiSW, umowa Nr 461252 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2020).