Development and validation of a fast and simple RP-HPLC method for the determination of diosmin and hesperidin in combined tablet dosage form

Authors

  • Marjan Piponski Replek Farm Ltd.
  • Tanja Bakovska Stoimenova Replek Farm Ltd.
  • Marina Topkoska Replek Farm Ltd.
  • Stefan Stefov Replek Farm Ltd.
  • Magdalena Piponska Replek Farm Ltd.
  • Gordana Trendovska Serafimovska Replek Farm Ltd.

DOI:

https://doi.org/10.20450/mjcce.2018.1448

Keywords:

Diosmin, Hesperidin, HPLC, UV, Method

Abstract

A fast, simple, accurate and robust reversed phase HPLC method for the simultaneous determination of two flavonoids, hesperidin and diosmin, in combined tablets was developed and validated. This method uses a short C8 column with dimensions of 75 mm × 4 mm with 5 µm particles thermostated at 30 °C, and a mobile phase composed of formic acid (pH 4.1 and 0.05%, V/V) and methanol (58:42, V/V), delivered at a flow rate of 1.2 ml/min, with UV detector signal monitoring at 280 nm and an injection volume of 5 µl. These chromatographic conditions yielded chromatograms with symmetric peaks of hesperidin, eluting at a ~2 min retention time, and diosmin, at a ~4.5 min retention time, with a total run time cycle of 6 min. The method validation parameters confirmed excellent values for accuracy, linearity and reproducibility. This method is suitable for routine analysis in pharmaceutical and food quality control laboratories.

Author Biographies

Marjan Piponski, Replek Farm Ltd.

Quality Control Department

Tanja Bakovska Stoimenova, Replek Farm Ltd.

Quality Control Department

Marina Topkoska, Replek Farm Ltd.

Quality Control Department

Stefan Stefov, Replek Farm Ltd.

Quality Control Department

Magdalena Piponska, Replek Farm Ltd.

Quality Control Department

Gordana Trendovska Serafimovska, Replek Farm Ltd.

Quality Control Department

References

[ ] Diosmin, monograph, Alternative Medicine Review, 9 (3), 308–311 (2004).

V. Kuntić, J. Brborić, I. Antunović-Holclajtner, S. Uskoković-Marković, Evaluating the bioactive effects of flavonoid hespeidin – A new literature data survey, Vojnosanitetski pregled, 71 (1), 60–65 (2014).

DOI: 10.2298/VSP1401060K.

P. Gloviczki (ed.), ass. eds. C. M. Dalsing, B. Eklof, L. G. Moneta, W. T. Wakefield, Handbook of Venous Dis-orders, 3rd ed., Guidelines of the American Venous Fo-rum, CRC Press, Taylor & Francis Group, LLC, 2008.

D. Srilatha, M. Nasare, B. Nagasandhya, V. Prasad, P. Diwan, Development and validation of UV spectropho-tometric method for simultaneous estimation of hesperidin and diosmin in the pharmaceutical dosage form, In-ternational Scholarly Research Notices (ISRN) Spec-troscopy 2013, 4 pages. DOI: 10.1155/2013/534830.

Z. Moldovan, A. A. Bunaciu, A. M. Al-Omar, Y. H. Aboul-Enein, A spectrophotometric method for diosmin determination, The Open Chemical and Biomedical Methods Journal, 3, 123–127 (2010).

M. Dalia, M. T. Shereen, Fluorimetric determination of diosmin and hesperidin in combined dosage forms and in plasma through complex formation with terbium, Bulletin of Faculty of Pharmacy, Cairo University, 51 (1), 81–88 (2013). DOI: 10.1016/j.bfopcu.2012.12.001.

M. A. El-Shafae, M. M. El-Domiaty, Improved LC methods for the determination of diosmin and/or hesper-idin in plant extracts and pharmaceutical formulations, Journal of Pharmaceutical and Biomedical Analysis, 26, 539–545 (2001).

I. F. Kanaze, C. Gabrieli, E. Kokkalou, M. Georgarakis, I. Niopas, Simultaneous reversed-phase high-performance liquid chromatographic method for the determination of diosmin, hesperidin and naringin in different citrus fruit juices and pharmaceutical formulations, Journal of Pharmaceutical and Biomedical Analysis, 33 (2), 243–249 (2003).

European Pharmacopoeia, 5th ed. European Directorate for the Quality of Medicines – Council of Europe: Strasbourg, 2004.

D. Šatinský, K. Jägerová, L. Havliková, P. Solich, A new and fast HPLC method for determination of rutin, troxerutin, diosmin and hesperidin in food supplements using fused-core column technology, Food Analytical Methods, 6 (5), 1353–1360 (2013).

DOI: 10.1007/s12161-012-9551-y.

G. Mishra, K. V. Srivastva, A. Tripathi, Analytical method development and validation for assay of diosmin and hesperidin in combined dosage form by RP-HPLC, International Journal of Pharmacy & Life Sciences, 4 (7), 2834–2839 (2013).

M. K. Anwer, S. Jamil, M. J. Ansari, R. Al-Shdefat, M. S. Abdel-Kader, A new improved stability-indicating RP-HPLC method for determination of diosmin and hesperidin in combination, International Research Jour-nal of Biological Sciences, 3 (6), 41–46 (2014).

B. Patel, K. Mittal, D. Damor, R. Mashru, Quality by design approach to analytical method development for simultaneous estimation of hesperidin methyl chalcone, hesperidin and ascorbic acid in their combined dosage form by RP-HPLC method, International Journal of Pharmacy & Pharmaceutical Research, 4 (2), 44–62 (2015).

F. Ibrahim, S. K. M. El-Din, N. R. El-Shaheny, K. A. El-Deen, K. Shimizu, Simultaneous determination of four vasoactive phytochemicals in different pharmaceutical preparations by a simple HPLC-DAD method, Analytical Methods, 8, 1858–1866 (2016).

DOI: 10.1039/C5AY03003J.

M. Szymański, D. Mlynarek, A. Szymański, I. Matlawska, Simultaneous determination of diosmin and hesperidin in pharmaceuticals by RPLC using ionic liq-uids as mobile phase modifiers, Iranian Journal of Pharmaceutical Research, 15 (1), 141–148 (2016).

V. Kuntić, N. Pejić, B. Ivković, Z. Vujić, K. Ilić, S. Mićić, V. Vukojević, Isocratic RP-HPLC method for rutin determination in solid oral dosage forms, Journal of Pharmaceutical and Biomedical Analysis, 43 (2), 718–721 (2007).

M. Biesaga, U. Ochnik, K. Pyrzynska, Fast analysis of prominent flavonoids in tomato using a monolithic col-umn and isocratic HPLC, Journal of Separation Science, 32 (15–16), 2835–2840 (2009).

M. F. Yam, E. A. Mohamed, L. F. Ang, L. Pei, Y. Darwis, R. Mahmud, M. Z. Asmawi, R. Basir, M. Ah-mad, A simple isocratic HPLC method for the simulta-neous determination of sinensetin, eupatorin, and 3’-hydroxy-5, 6,7, 4’-tetramethoxyflavone in Orthosiphon stamineus extracts, Journal of Acupuncture and Meridian Studies, 5 (4), 176–182 (2012).

M. N. Islam, H. J. Chung, D. H Kim, H. H. Yoo, A sim-ple isocratic HPLC method for the simultaneous deter-mination of bioactive components of Scutellariae radix extract, Natural Product Research, 26 (21), 1957–1962 (2012).

J. Dolan, A Guide to HPLC and LC-MS Buffer Selection, ACE HPLC Columns, Advanced Chromatography Tech-nologies, Aberdeen, Scotland. Available from: www.ace-hplc.com [accessed 02.12.2016].

International Conference on Harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use, Validation of Analytical Procedures: Text and Methodology Q2(R1), ICH, Geneva, Switzerland, 2005.

Downloads

Published

2018-11-07

How to Cite

Piponski, M., Bakovska Stoimenova, T., Topkoska, M., Stefov, S., Piponska, M., & Trendovska Serafimovska, G. (2018). Development and validation of a fast and simple RP-HPLC method for the determination of diosmin and hesperidin in combined tablet dosage form. Macedonian Journal of Chemistry and Chemical Engineering, 37(2), 127–134. https://doi.org/10.20450/mjcce.2018.1448

Issue

Section

Analytical Chemistry