Journals / İstanbul Journal of Pharmacy / 2021 / Cilt: 51 - Sayı: 1

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

Pages
16–25
Publication Date
2021-04-30
DOI
—
🏛️Bibliographic metadata and full text access for this article are provided via DergiPark.
DergiPark Record ↗
✨

AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

Results: Analytical recovery of esomeprazole was between 92.43 and 105.36% and for pirfenidone it was found between 89.56 and 104.32%.

📌 3 Key Takeaways

🎯
Objective & Hypothesis: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.
📊
Key Findings & Data: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.
💡
Conclusion & Impact:Results: Analytical recovery of esomeprazole was between 92.43 and 105.36% and for pirfenidone it was found between 89.56 and 104.32%.
🔬Design:Research Article
📍Scope:Comprehensive Sample
⚙️Variables:Esomeprazole · pirfenidone · rat plasma

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.

🔖

Cite This Article

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, Cilt: 51 - Sayı: 1, 16–25. https://ajindex.com/articles/161880

📄 Full Text PDF Viewer

📄

PDF görüntüleyici hazırlanıyor...

References (1)

  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. • 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. • 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. • 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. • 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. • 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. • 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. • 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. • Hodgson, U., Laitinen, T., & Tukiainen, P. (2002). Nationwide prevalence of sporadic and familial idiopathic pulmonary fibrosis: evidence of founder effect among multiplex families in Finland. Thorax, 57(4), 338–342. • ICH, I. (2005). Q2 (R1): Validation of analytical procedures: Text and methodology. In International Conference on Harmonization, Geneva. • Iyer, S. N., Wild, J. S., Schiedt, M. J., Hyde, D.M., Margolin, S. B.,