Research Article
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Year 2020, Volume: 50 Issue: 1, 16 - 20, 01.04.2020

Abstract

References

  • • Abdelrahman, M. M., Abdelaleem, E. A., Ali, N. W., & Emam, R. A. (2016). Simultaneous determination of Carbazochrome and Troxerutin in their binary mixture by HPLC and HPTLC-Densitometric methods. Bulletin of Faculty of Pharmacy, Cairo University, 54(1), 67–75.
  • • Basile, M., Gidaro, S., Pacella, M., Biffignandi, P. M., & Gidaro, G. S. (2001). Parenteral troxerutin and carbazochrome combination in the treatment of post-hemorrhoidectomy status: A randomized, double-blind, placebo-controlled, phase IV study. Current Medical Research and Opinion, 17(4), 256–261.
  • • Chen, Y. H., Ren, K.,Tian F. S., Zhu, K. K., & Hu, X. Y. (2015). Spectrofluorimetric and spectrophotometric determination of troxerutin in pharmaceutical preparations. Asian Journal of Chemıstry, 27(5), 1854–1856.
  • • Cui, X., Zhang, M., Guan, X., Yin, L., Sun, Y., Fawcett, J. P., & Gu, J. (2011). LC–MS–MS determination of troxerutin in plasma and its application to a pharmacokinetic study. Chromatographia, 73(1), 165–169.
  • • European Medicines Agency. (1995). ICH Q2 (R1) validation of analytical procedures: Text and methodology. Retrieved from https://www. ema.europa.eu/documents/scientific-guideline/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf
  • • European Medicines Agency. (2011). Guideline on bioanalytical method validation. Retrived from https://www.ema.europa.eu/ en/documents/scientific-guideline/guideline-bioanalyticalmethod-validation_en.pdf
  • • Gan, X., Liu, S., Liu, Z., Hu, X., Cui, Z., & Wang, Y. (2012). Determination of carbazochrome by fluorescence quenching method. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 97, 161–166.
  • • Guo, H-Z., Ron, C., Bı, K-S., & Sun, Y-Q. (2004). Determination of troxerutin in venoruton injections and venoruton tabletsby short capillary zone electrophoresis. Chinese Journal of Pharmaceutical Analysis, 24(5), 457–459.
  • • Hayes, R., Ahmed, A., Edge, T., & Zhang, H. (2014). Core-shell particles: Preparation, fundamentals and applications in high performance liquid chromatography. Journal of Chromatography A, 1357, 36–52.
  • • Hepsebah, N., Nihitha, D., & Kumar, A. A. (2014). Reverse phase HPLC method development and validation for the simultaneous quantitative estimation of Troxerutin and calcium dobesilate in tablets. International Journal of Pharmacy and Pharmaceutical Sciences, 6(1), 333–339.
  • • Hu, X., Zheng, Y., Wu, G., Liu, J., Zhu, M., Zhou, H. ... Shen-Tu, J. (2014). Optimization of solid phase extraction clean up and validation of quantitative determination of carbazochrome sodium sulfonate in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 951–952, 1–6.
  • • Joseph, J., & Deepthi, K. (2015). Development and validation of analytical methods for the simultaneous estimation of troxerutin and calcium dobesilate in bulk and pharmaceutical dosage form. Indo American Journal of Pharmaceutical Research, 5(9), 1–7.
  • • Khattab, F. I., Ramadan, N. K., Hegazy, M. A., Al-Ghobashy, M. A., & Ghoniem, N. S. (2015). Validated spectrophotometric methods for simultaneous determination of troxerutin and carbazochrome in dosage form. Spectrochim Acta A Mol Biomol Spectroscopy, 139, 206–213.
  • • Reviewer Guidance, Validation of Chromatographic Methods. FDA (Center for Drug Evaluation and Research, U.S. Food and Drug Administration). (1994). https://www.fda.gov/downloads/Drugs/ Guidances/UCM134409.pdf
  • • Song, M., Zhao, H., Wang, L., Yang, L., Hang, T., & Wen, A. (2010). Development and validation of a robust LC-MS-MS with atmospheric pressure chemical ionization for quantitation of carbazochrome sodium sulfonate in human plasma: Application to a pharmacokinetic study. Biomed Chromatography, 24(9), 990–999.
  • • Squadrito, F., Altavilla, D., & Oliaro Bosso, S. (2000). Double-blind, randomized clinical trial of troxerutin-carbazochrome in patients with hemorrhoids. European Review for Medical and Pharmacological Sciences, 4(1–2), 21–24.
  • • Wang, L. Fu, Z., & Wang, Y. (2011). Cation exchange solid-phase extraction coupled with flow injection chemiluminescent analysis for detection of carbazochrome. Chinese Journal of Pharmaceutical Analysis, 31(10), 1934–1937.
  • • Wu, H., & Liu, F. (2008). Determination of carbazochrome sodium sulfonate for injection by UV spectrophotometry [J]. Anhui Medical and Pharmaceutical Journal, 1(12), 18–19.
  • • Yang, G. J., Liu, P., Qu, X. L., Xu, M. J., Qu, Q. S., Wang, C. Y. … Wang Z. Y. (2007). The simultaneous separation and determination of six flavonoids and troxerutin in rat urine and chicken plasma by reversed-phase high-performance liquid chromatography with ultraviolet-visible detection. J Chromatography B Analytical Technologies in Biomedical Life Sciences, 856(1–2), 222–228.

Core shell column in high-performance liquid chromatography for the determination of polar compounds; troxerutin and carbazochrome

Year 2020, Volume: 50 Issue: 1, 16 - 20, 01.04.2020

Abstract

Background and Aims: The combination of troxerutin and carbazochrome has been found efficacious for non-surgical patients with acute uncomplicated hemorrhoids. Therefore it is essential to develop a simultaneous analysis method of those drug substances. This study explains a simple and selective HPLC method to analyze troxerutin and carbazohrome in tablets. Methods: The analysis was carried out using a core-shell pentafluorophenyl propyl polar column with a mobile phase consisting of (MeOH; % 5 HAc), (99.5:0.5 - V/V) at a flow rate of 0.25 mL/min. UV detection was set to 350 nm. Results: The standard calibration curve was established between 1.00-20.00 μg/mL for troxerutin; 0.05-1.00 μg/mL for carbazochrome. LOD and LOQ were found to be 0.65 μg/mL and 1.00 μg/mL for troxerutin and 0.01 μg/mL and 0.05 μg/mL for carbazochrome, respectively. Conclusion: The proposed method was validated for specificity, linearity, accuracy, precision, LOQ and LOD and then successfully applied for the analysis of these substances in tablets.

References

  • • Abdelrahman, M. M., Abdelaleem, E. A., Ali, N. W., & Emam, R. A. (2016). Simultaneous determination of Carbazochrome and Troxerutin in their binary mixture by HPLC and HPTLC-Densitometric methods. Bulletin of Faculty of Pharmacy, Cairo University, 54(1), 67–75.
  • • Basile, M., Gidaro, S., Pacella, M., Biffignandi, P. M., & Gidaro, G. S. (2001). Parenteral troxerutin and carbazochrome combination in the treatment of post-hemorrhoidectomy status: A randomized, double-blind, placebo-controlled, phase IV study. Current Medical Research and Opinion, 17(4), 256–261.
  • • Chen, Y. H., Ren, K.,Tian F. S., Zhu, K. K., & Hu, X. Y. (2015). Spectrofluorimetric and spectrophotometric determination of troxerutin in pharmaceutical preparations. Asian Journal of Chemıstry, 27(5), 1854–1856.
  • • Cui, X., Zhang, M., Guan, X., Yin, L., Sun, Y., Fawcett, J. P., & Gu, J. (2011). LC–MS–MS determination of troxerutin in plasma and its application to a pharmacokinetic study. Chromatographia, 73(1), 165–169.
  • • European Medicines Agency. (1995). ICH Q2 (R1) validation of analytical procedures: Text and methodology. Retrieved from https://www. ema.europa.eu/documents/scientific-guideline/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf
  • • European Medicines Agency. (2011). Guideline on bioanalytical method validation. Retrived from https://www.ema.europa.eu/ en/documents/scientific-guideline/guideline-bioanalyticalmethod-validation_en.pdf
  • • Gan, X., Liu, S., Liu, Z., Hu, X., Cui, Z., & Wang, Y. (2012). Determination of carbazochrome by fluorescence quenching method. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy, 97, 161–166.
  • • Guo, H-Z., Ron, C., Bı, K-S., & Sun, Y-Q. (2004). Determination of troxerutin in venoruton injections and venoruton tabletsby short capillary zone electrophoresis. Chinese Journal of Pharmaceutical Analysis, 24(5), 457–459.
  • • Hayes, R., Ahmed, A., Edge, T., & Zhang, H. (2014). Core-shell particles: Preparation, fundamentals and applications in high performance liquid chromatography. Journal of Chromatography A, 1357, 36–52.
  • • Hepsebah, N., Nihitha, D., & Kumar, A. A. (2014). Reverse phase HPLC method development and validation for the simultaneous quantitative estimation of Troxerutin and calcium dobesilate in tablets. International Journal of Pharmacy and Pharmaceutical Sciences, 6(1), 333–339.
  • • Hu, X., Zheng, Y., Wu, G., Liu, J., Zhu, M., Zhou, H. ... Shen-Tu, J. (2014). Optimization of solid phase extraction clean up and validation of quantitative determination of carbazochrome sodium sulfonate in human plasma by liquid chromatography-electrospray ionization tandem mass spectrometry. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 951–952, 1–6.
  • • Joseph, J., & Deepthi, K. (2015). Development and validation of analytical methods for the simultaneous estimation of troxerutin and calcium dobesilate in bulk and pharmaceutical dosage form. Indo American Journal of Pharmaceutical Research, 5(9), 1–7.
  • • Khattab, F. I., Ramadan, N. K., Hegazy, M. A., Al-Ghobashy, M. A., & Ghoniem, N. S. (2015). Validated spectrophotometric methods for simultaneous determination of troxerutin and carbazochrome in dosage form. Spectrochim Acta A Mol Biomol Spectroscopy, 139, 206–213.
  • • Reviewer Guidance, Validation of Chromatographic Methods. FDA (Center for Drug Evaluation and Research, U.S. Food and Drug Administration). (1994). https://www.fda.gov/downloads/Drugs/ Guidances/UCM134409.pdf
  • • Song, M., Zhao, H., Wang, L., Yang, L., Hang, T., & Wen, A. (2010). Development and validation of a robust LC-MS-MS with atmospheric pressure chemical ionization for quantitation of carbazochrome sodium sulfonate in human plasma: Application to a pharmacokinetic study. Biomed Chromatography, 24(9), 990–999.
  • • Squadrito, F., Altavilla, D., & Oliaro Bosso, S. (2000). Double-blind, randomized clinical trial of troxerutin-carbazochrome in patients with hemorrhoids. European Review for Medical and Pharmacological Sciences, 4(1–2), 21–24.
  • • Wang, L. Fu, Z., & Wang, Y. (2011). Cation exchange solid-phase extraction coupled with flow injection chemiluminescent analysis for detection of carbazochrome. Chinese Journal of Pharmaceutical Analysis, 31(10), 1934–1937.
  • • Wu, H., & Liu, F. (2008). Determination of carbazochrome sodium sulfonate for injection by UV spectrophotometry [J]. Anhui Medical and Pharmaceutical Journal, 1(12), 18–19.
  • • Yang, G. J., Liu, P., Qu, X. L., Xu, M. J., Qu, Q. S., Wang, C. Y. … Wang Z. Y. (2007). The simultaneous separation and determination of six flavonoids and troxerutin in rat urine and chicken plasma by reversed-phase high-performance liquid chromatography with ultraviolet-visible detection. J Chromatography B Analytical Technologies in Biomedical Life Sciences, 856(1–2), 222–228.
There are 19 citations in total.

Details

Primary Language English
Subjects Pharmacology and Pharmaceutical Sciences, Health Care Administration
Journal Section Original Article
Authors

Merve Keşkek Arslan This is me 0000-0002-5758-9528

Durişehvar Özer Ünal This is me 0000-0003-0754-1240

Publication Date April 1, 2020
Submission Date March 6, 2019
Published in Issue Year 2020 Volume: 50 Issue: 1

Cite

APA Keşkek Arslan, M., & Özer Ünal, D. (2020). Core shell column in high-performance liquid chromatography for the determination of polar compounds; troxerutin and carbazochrome. İstanbul Journal of Pharmacy, 50(1), 16-20.
AMA Keşkek Arslan M, Özer Ünal D. Core shell column in high-performance liquid chromatography for the determination of polar compounds; troxerutin and carbazochrome. iujp. April 2020;50(1):16-20.
Chicago Keşkek Arslan, Merve, and Durişehvar Özer Ünal. “Core Shell Column in High-Performance Liquid Chromatography for the Determination of Polar Compounds; Troxerutin and Carbazochrome”. İstanbul Journal of Pharmacy 50, no. 1 (April 2020): 16-20.
EndNote Keşkek Arslan M, Özer Ünal D (April 1, 2020) Core shell column in high-performance liquid chromatography for the determination of polar compounds; troxerutin and carbazochrome. İstanbul Journal of Pharmacy 50 1 16–20.
IEEE M. Keşkek Arslan and D. Özer Ünal, “Core shell column in high-performance liquid chromatography for the determination of polar compounds; troxerutin and carbazochrome”, iujp, vol. 50, no. 1, pp. 16–20, 2020.
ISNAD Keşkek Arslan, Merve - Özer Ünal, Durişehvar. “Core Shell Column in High-Performance Liquid Chromatography for the Determination of Polar Compounds; Troxerutin and Carbazochrome”. İstanbul Journal of Pharmacy 50/1 (April 2020), 16-20.
JAMA Keşkek Arslan M, Özer Ünal D. Core shell column in high-performance liquid chromatography for the determination of polar compounds; troxerutin and carbazochrome. iujp. 2020;50:16–20.
MLA Keşkek Arslan, Merve and Durişehvar Özer Ünal. “Core Shell Column in High-Performance Liquid Chromatography for the Determination of Polar Compounds; Troxerutin and Carbazochrome”. İstanbul Journal of Pharmacy, vol. 50, no. 1, 2020, pp. 16-20.
Vancouver Keşkek Arslan M, Özer Ünal D. Core shell column in high-performance liquid chromatography for the determination of polar compounds; troxerutin and carbazochrome. iujp. 2020;50(1):16-20.