Bioanalytical method validation of Esomeprazole by high performance liquid chromatography with PDA detection

• Autorzy: Moni Fatema , Sharmin Suriya , Rony Satyajit Roy , Afroz Farhana , Akhter Shammi , Sohrab Md. Hossain

Identyfikatory

DOI

10.1556/1326.2020.00769

• Języki publikacji: EN

Abstrakty

EN

This study describes the development and validation of a simple, specific, accurate, and precise method for quantitative determination of Esomeprazole in human serum using Pantoprazole as internal standard (IS). After the addition of internal standard, Esomeprazole from serum samples was extracted simply by protein precipitation method followed by centrifugation and the supernatants were directly injected into the high performance liquid chromatography (HPLC). The chromatographic separation of the compounds was obtained on Hitachi Lachrom C8 column (5 µm, 250 × 4.6 mm) with a mobile phase consisting of 5 mM potassium dihydrogen phosphate pH 7.4 and acetonitrile in a ratio of 70:30 with UV detection at 302 nm with a flow rate of 1 mL/min. The method was sensitive and specific, and validated over a concentration range of 0.06–6.0 µg/mL. The limit of detection (LOD) and lower limit of quantification (LOQ) was 0.03 µg/mL and 0.06 µg/mL, respectively. The precision and accuracy expressed as relative standard deviation were less than 15%. The average recovery of Esomeprazole from serum was 97.08%.

Słowa kluczowe

EN

bioanalytical method validation; esomeprazole; pantoprazole; HPLC

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2021
• Tom: Vol. 33, no. 2
• Strony: 120--126
• Opis fizyczny: Bibliogr. 16 poz., rys., tab.

Twórcy

autor

Moni Fatema

• Pharmaceutical Sciences Research Division, BCSIR Laboratories Dhaka, Bangladesh Council of Scientific and Industrial Research (BCSIR), Dhaka, 1205, , Bangladesh

autor

Sharmin Suriya

• Pharmaceutical Sciences Research Division, BCSIR Laboratories Dhaka, Bangladesh Council of Scientific and Industrial Research (BCSIR), Dhaka, 1205, , Bangladesh

autor

Rony Satyajit Roy

• Pharmaceutical Sciences Research Division, BCSIR Laboratories Dhaka, Bangladesh Council of Scientific and Industrial Research (BCSIR), Dhaka, 1205, , Bangladesh

autor

Afroz Farhana

• Pharmaceutical Sciences Research Division, BCSIR Laboratories Dhaka, Bangladesh Council of Scientific and Industrial Research (BCSIR), Dhaka, 1205, , Bangladesh

autor

Akhter Shammi

• Pharmaceutical Sciences Research Division, BCSIR Laboratories Dhaka, Bangladesh Council of Scientific and Industrial Research (BCSIR), Dhaka, 1205, , Bangladesh

autor

Sohrab Md. Hossain

• Pharmaceutical Sciences Research Division, BCSIR Laboratories Dhaka, Bangladesh Council of Scientific and Industrial Research (BCSIR), Dhaka, 1205, , Bangladesh

• https://orcid.org/0000-0002-8314-2594

Bibliografia

• 1. Hassan-Alin, M.; Andersson, T.; Bredberg, E.; R€ohss, K. Eur J Clin Pharmacol. 2000, 56, 665–670.
• 2. Islam, M. S.; Akter N.; Shohag, H.; Ullah, A.; Maruf, A. A.; Sultana, T. A.; Latif, A. H.M.; Hasnat, A. J Bioequiv Availab. 2011, 3(6), 139–143.
• 3. Jones, B.; Kenward, G. M. Design and Analysis of Cross-over Trials, 2nd ed.; Champman and Hall/CRC, 2003.
• 4. Nahar, K.; Joti, J. J.; Ullah, M. A.; Hasan. A.; Azad, M. A. K. Dhaka Univ J Pharm Sci. 2009, 8, 123–130.
• 5. Brunton, L. L.; Lazo, J. S.; Parker, K. L. Goodman & Gilman’s, The Pharmacological Basis of Therapeutics, 11th ed., McGraw-Hill Education, 2005.
• 6. Anderson, T.; Hassan-Alin, M.; Hasselgren, G.; Rohss, K.; Weidol, L. Clin. Pharmacokinet. 2001, 40(6), 411–426.
• 7. Department of Health and Human Services, Food and Drug Administration. Bioanalytical Method Validation Guidance for Industry. 7500 Standish Place: Rockville, MD 20855, 2018, https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf (Accessed January, 26, 2020).
• 8. Harahap, Y.; Baskara, A. E.; Harmita. J. Young Pharm. 2017, 9(Suppl. 1), s24–s28.
• 9. Cai, W.; Wang, Z.; Li, J.; Hu, J.; Zhong, J. Arzneimittelforschung 2011, 61(9), 502–505.
• 10. Chunduri, R. H. B.; Dannana, G. S. J. Pharma. Anal. 2016, 6, 190–198.
• 11. Hultman, I.; Stenhoff, H.; Liljeblad, M. J. Chromatogr. B 2007, 848, 317–322.
• 12. Ahuja, S.; Michael, W. D. Hand Book of Pharmaceutical Analysis by HPLC, 6th ed.; Elsevier academic press: Amsterdam, 2005; pp 197–206.
• 13. Rosing, H.; Man, W.Y.; Doyle, E.; Bult, A.; Beijnen, H. J. J. Liq. Chromatogr. Relat. Technol. 2000, 23, 329–354.
• 14. Nascimento, T. G.; Oliveria, E. J.; Macedo, R. O. J. Pharm. Biomed. Anal. 2005, 37, 777–783.
• 15. Polson, C.; Sarker, Pratibha.; Incledon, B.; Raguvaran, V.; Grant, R. J. Chromatogr. B 2003, 785, 263–275.
• 16. Shah, V. P.; Midha, K. K.; Findlay, J. W. A.; Hill, H. M.; Hulse, J. D.; McGilveray, I. J.;McKay,G.; Miller, K. J.; Patnaik, R. N.; Powell, M. L.; Tonelli, A.; Viswanathan, C. T.; Yacobi, A. Pharm. Res. 2000, 17, 1551–1557.

Uwagi

Opracowanie rekordu ze środków MNiSW, umowa Nr 461252 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2021).