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

Yıl 2021, Cilt: 51 Sayı: 1, 16 - 25, 30.04.2021

Emrah Dural Sema Tülay Köz Süleyman Köz

Öz

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.

Anahtar Kelimeler

Esomeprazole, pirfenidone, rat plasma, method validation, HPLC-UV

Kaynakça

• • 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., & Giri, S. N. (1995). Dietary intake of pirfenidone ameliorates bleomycininduced lung fibrosis in hamsters. The Journal of Laboratory and Clinical Medicine, 125(6), 779–785.
• • Jain, D. K., Jain, N., Charde, R., & Jain, N. (2011). The RP-HPLC method for simultaneous estimation of esomeprazole and naproxen in binary combination. Pharmaceutical Methods, 2(3), 167–172.
• • Johnson, D. A. (2003). Review of esomeprazole in the treatment of acid disorders. Expert Opinion on Pharmacotherapy, 4(2), 253–264.
• • Kayesh, R., & Sultan, M. Z. (2015). A novel ion-pair RP-HPLC method for simultaneous quantification of naproxen and esomeprazole in pharmaceutical formulations. Journal of Chromatographic Science, 53(5), 687–693.
• • Kehrer, J.P., & Margolin, S.B. (1997). Pirfenidone diminishes cyclophosphamide- induced lung fibrosis in mice. Toxicology Letters, 90(2–3), 125–132.
• • Liu, R., Li, P., Xiao, J., Yin, Y., Sun, Z., Bi, K., & Li, Q. (2017). A fast, sensitive, and high throughput method for the determination of esomeprazole in dog plasma by UHPLC–MS/MS: Application to formulation development of the compound preparation of esomeprazole. Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 1068–1069, 352–357.
• • Ma, J., Sun, F., Chen, B., Tu, X., Peng, X., Wen, C. … Wang, X. (2017). Tissue metabolic changes for effects of pirfenidone in rats of acute paraquat poisoning by GC-MS. Toxicology and Industrial Health, 33(12), 887–900.
• • Marshall, R.P., Puddicombe, A., Cookson, W.O., & Laurent, G.J. (2000). Adult familial cryptogenic fibrosing alveolitis in the United Kingdom. Thorax, 55(2), 143–146.
• • Mercolini, L., Mandrioli, R., Amore, M., & Raggi, M. A. (2008). Separation and HPLC analysis of 15 benzodiazepines in human plasma. Journal of Separation Science, 31(14), 2619–2626.
• • More, S., Dalwate, S., Chandramore, N., Jadhav, V., & Jain, A. (2019). Development of chromatographic method and validation for estimation of pirfenidone in bulk and pharmaceutical dosage form. International Research Journal of Pharmacy, 10(7), 45–50.
• • Khan, M.M.G., Shirkhedkar, A., Chaudhari, P., & Pawara, P.I. (2019). Analytical techniques for pirfenidone and terizidone: a review. International Journal of Pharmaceutical Chemistry and Analysis, 6(1), 1–5.
• • Nadrous, H.F., Myers, J.L., Decker, P.A., & Ryu, J.H. (2005). Idiopathic pulmonary fibrosis in patients younger than 50 years. Mayo Clinic Proceedings, 80(1), 37–40.
• • Parmar, V.K., Desai, S.B., & Vaja, T. (2014). RP-HPLC and UV spectrophotometric methods for estimation of pirfenidone in pharmaceutical formulations. Indian Journal of Pharmaceutical Sciences, 76(3), 225–229.
• • Prabu, S.L., Shirwaikar, A., Shirwaikar, A., Kumar, C.D., Joseph, A., & Kumar, R. (2008). Simultaneous estimation of esomeprazole and domperidone by UV spectrophotometric method. Indian Journal of Pharmaceutical Sciences, 70(1), 128–131.
• • Raghu, G., Chen, S.-Y., Yeh, W.-S., Maroni, B., Li, Q., Lee, Y.-C., & Collard, H. R. (2014). Idiopathic pulmonary fibrosis in US Medicare beneficiaries aged 65 years and older: incidence, prevalence, and survival, 2001-11. The Lancet. Respiratory Medicine, 2(7), 566–572.
• • Raman, N.V.V.S.S., Reddy, K.R., Prasad, A.V.S.S., & Ramakrishna, K. (2008). Development and validation of a GC–MS method for the determination of methyl and ethyl camphorsulfonates in esomeprazole magnesium. Chromatographia, 68(7), 675–678.
• • Ravisankar, P., Anusha Rani, K., Devadasu, C., & Devala Rao, G. (2014). A novel validated RP-HPLC method for the determination of pirfenidone in pharmaceutical dosage forms. Der Pharmacia Lettre, 6(5), 19–29.
• • Sambhani, N.G., & Biju, V.M.N. (2018). A micelle-enhanced spectrofluorimetric determination of pirfenidone: application to content uniformity testing and human urine. Journal of Fluorescence, 28(4), 951–957.
• • Sebaiy, M.M., Hassan, W.S., & Elhennawy, M.E. (2019). Developing a high-performance liquid chromatography (HPLC) method for simultaneous determination of oxytetracycline, tinidazole and esomeprazole in human plasma. Journal of Chromatographic Science, 57(8), 724–729.
• • Sotgia, S., Fois, A.G., Sotgiu, E., Zinellu, A., Paliogiannis, P., Mangoni, A.A., & Carru, C. (2020). Micellar electrokinetic capillary chromatographic determination of pirfenidone and 5-carboxy-pirfenidone by direct injection of plasma from patients receiving treatment for idiopathic pulmonary fibrosis (IPF). Microchemical Journal, 154, 104536.
• • Talaat, W. (2017). Bioanalytical method for the estimation of coadministered esomeprazole, leflunomide and ibuprofen in human plasma and in pharmaceutical dosage forms using micellar liquid chromatography. Biomedical Chromatography, 31(5).
• • Thorat, S.G., Padmane, S.P., Tajne, M.R., & Ittadwar, A.M. (2016). Development and validation of simple, rapid and sensitive UV, HPLC and HPTLC methods for the estimation of pirfenidone in tablet dosage form. Journal of the Chilean Chemical Society, 61(2), 2978–2981.
• • Tong, S., Wang, X., Jiang, H., Xu, X., Pan, Y., Chen, K. … Hu, G. (2010). Determination of pirfenidone in rat plasma by LC–MS-MS and its application to a pharmacokinetic study. Chromatographia, 71(7), 709–713.
• • Wang, Y., Zhao, X., Zhong, J., Chen, Y., Liu, X., & Wang, G. (2006). Simple determination of pirfenidone in rat plasma via high-performance liquid chromatography. Biomedical Chromatography, 20(12), 1375–1379.
• • Wen, Y.-G., Liu, X., He, X.-L., Shang, D.-W., Ni, X.-J., Zhang, M. … Qiu, C. (2014). Simultaneous determination of pirfenidone and its metabolite in human plasma by liquid chromatography–tandem mass spectrometry: application to a pharmacokinetic study. Journal of Analytical Toxicology, 38(9), 645–652.