Research Article

Development and validation an HPLC - UV method for determination of esomeprazole and pirfenidone simultaneously in rat plasma: application to a drug monitoring study

Volume: 51 Number: 1 April 30, 2021
  • Emrah Dural *
  • Sema Tülay Köz
  • Süleyman Köz

Development and validation an HPLC - UV method for determination of esomeprazole and pirfenidone simultaneously in rat plasma: application to a drug monitoring study

Abstract

Background and Aims: It has been observed that the combined treatment of esomeprazole and pirfenidone provides increased efficacy in the treatment of pulmonary fibrosis disease, recently. The aim of this study is to develop a simple, sensitive, and reliable high-performance liquid chromatography method to be used in drug monitoring to increase the effectiveness of esomeprazole and pirfenidone in treatment and to reduce their adverse effects. Methods: Separation was conducted with a C18 reverse-phase column (4.6 mm x 250 mm, 5 μm) used as a mobile phase prepared with the phosphate buffer (10 mM KH2PO4 and 10 mM K2HPO4) and acetonitrile (60:40, v/v) by an isocratic flow (1 mL/min). Mobile phase pH was adjusted to 3.0. Ultraviolet detection was accomplished at 305 nm. The column oven was held at 35°C to ensure an efficient analytical separation. Results: Analytical recovery of esomeprazole was between 92.43 and 105.36% and for pirfenidone it was found between 89.56 and 104.32%. Accuracy values of esomeprazole and pirfenidone were determined between (-2.90) – 4.22 and (-4.45) – 5.78, respectively. Precision (RSD%) was ≤7.89. The quantification limit was determined as 0.58 and 0.36 ng/mL. Plasma esomeprazole and pirfenidone levels were found as 0.87-8296.87 ng/mL (612.99±2212.20, mean ± standard deviation) and 0.45-238.60 ng/mL (61.44±76.35, mean ± standard deviation), respectively. Conclusion: Unexpectedly high RSD values were observed in both plasma (360.88%) and dose-rated results (89.61%) of esomeprazole, and pirfenidone were thought to be related to individual metabolism differences.

Keywords

References

  1. • Bodempudi, S.B., Babur, R., & Reddy, K.S. (2015). Development and substantiation of a RP-HPLC method for monitoring of impurities in pirfenidone drug substance. American Journal of Analytical Chemistry, 06(13), 1019–1029.
  2. • Çelebi, A., Aydın, D., Kocaman, O., Konduk, B.T., Şentürk, Ö., & Hülagü, S. (2016). Comparison of the effects of esomeprazole 40 mg, rabeprazole 20 mg, lansoprazole 30 mg, and pantoprazole 40 mg on intragastrıc pH in extensive metabolizer patients with gastroesophageal reflux disease. The Turkish Journal of Gastroenterology, 27(5), 408–414.
  3. • Eltahir, H.M., & Nazmy, M.H. (2018). Esomeprazole ameliorates CCl4 induced liver fibrosis in rats via modulating oxidative stress, inflammatory, fibrogenic and apoptotic markers. Biomedicine and Pharmacotherapy, 97, 1356–1365.
  4. • Estevez, P., Flor, S., Boscolo, O., Tripodi, V., & Lucangioli, S. (2014). Development and validation of a capillary electrophoresis method for determination of enantiomeric purity and related substances of esomeprazole in raw material and pellets. Electrophoresis, 35(6), 804–810.
  5. • Franke, A., Hepp, C., Harder, H., Beglinger, C., & Singer, M. V. (2008). Esomeprazole reduces gastroesophageal reflux after beer consumption in healthy volunteers. Scandinavian Journal of Gastroenterology, 43(12), 1425–1431.
  6. • Ghebre, Y.T., & Raghu, G. (2016). Idiopathic pulmonary fibrosis: Novel concepts of proton pump inhibitors as antifibrotic drugs. American Journal of Respiratory and Critical Care Medicine, 193(12), 1345–1352.
  7. • Ghebremariam, Y.T., Cooke, J.P., Gerhart, W., Griego, C., Brower, J.B., Doyle-Eisele, M., … Rosen, G.D. (2015). Pleiotropic effect of the proton pump inhibitor esomeprazole leading to suppression of lung inflammation and fibrosis. Journal of Translational Medicine, 13(1), 1–20.
  8. • Gopinath, S., Kumar, R.S., Shankar, M.B., & Danabal, P. (2013). Development and validation of a sensitive and high-throughput LC-MS/MS method for the simultaneous determination of esomeprazole and naproxen in human plasma. Biomedical Chromatography, 27(7), 894–899.

Details

Primary Language

English

Subjects

Pharmacology and Pharmaceutical Sciences, Health Care Administration

Journal Section

Research Article

Authors

Emrah Dural * This is me
0000-0002-9320-8008
Türkiye

Sema Tülay Köz This is me
0000-0002-3809-1070
Türkiye

Süleyman Köz This is me
0000-0001-5036-0475
Türkiye

Publication Date

April 30, 2021

Submission Date

September 18, 2020

Acceptance Date

December 21, 2020

Published in Issue

Year 2021 Volume: 51 Number: 1

APA
Dural, E., Köz, S. T., & Köz, S. (2021). Development and validation an HPLC - UV method for determination of esomeprazole and pirfenidone simultaneously in rat plasma: application to a drug monitoring study. İstanbul Journal of Pharmacy, 51(1), 16-25. https://izlik.org/JA43TK48TX
AMA
1.Dural E, Köz ST, Köz S. Development and validation an HPLC - UV method for determination of esomeprazole and pirfenidone simultaneously in rat plasma: application to a drug monitoring study. iujp. 2021;51(1):16-25. https://izlik.org/JA43TK48TX
Chicago
Dural, Emrah, Sema Tülay Köz, and Süleyman Köz. 2021. “Development and Validation an HPLC - UV Method for Determination of Esomeprazole and Pirfenidone Simultaneously in Rat Plasma: Application to a Drug Monitoring Study”. İstanbul Journal of Pharmacy 51 (1): 16-25. https://izlik.org/JA43TK48TX.
EndNote
Dural E, Köz ST, Köz S (April 1, 2021) Development and validation an HPLC - UV method for determination of esomeprazole and pirfenidone simultaneously in rat plasma: application to a drug monitoring study. İstanbul Journal of Pharmacy 51 1 16–25.
IEEE
[1]E. Dural, S. T. Köz, and S. Köz, “Development and validation an HPLC - UV method for determination of esomeprazole and pirfenidone simultaneously in rat plasma: application to a drug monitoring study”, iujp, vol. 51, no. 1, pp. 16–25, Apr. 2021, [Online]. Available: https://izlik.org/JA43TK48TX
ISNAD
Dural, Emrah - Köz, Sema Tülay - Köz, Süleyman. “Development and Validation an HPLC - UV Method for Determination of Esomeprazole and Pirfenidone Simultaneously in Rat Plasma: Application to a Drug Monitoring Study”. İstanbul Journal of Pharmacy 51/1 (April 1, 2021): 16-25. https://izlik.org/JA43TK48TX.
JAMA
1.Dural E, Köz ST, Köz S. Development and validation an HPLC - UV method for determination of esomeprazole and pirfenidone simultaneously in rat plasma: application to a drug monitoring study. iujp. 2021;51:16–25.
MLA
Dural, Emrah, et al. “Development and Validation an HPLC - UV Method for Determination of Esomeprazole and Pirfenidone Simultaneously in Rat Plasma: Application to a Drug Monitoring Study”. İstanbul Journal of Pharmacy, vol. 51, no. 1, Apr. 2021, pp. 16-25, https://izlik.org/JA43TK48TX.
Vancouver
1.Emrah Dural, Sema Tülay Köz, Süleyman Köz. Development and validation an HPLC - UV method for determination of esomeprazole and pirfenidone simultaneously in rat plasma: application to a drug monitoring study. iujp [Internet]. 2021 Apr. 1;51(1):16-25. Available from: https://izlik.org/JA43TK48TX