Pharmacokinetic Study and Incurred Sample Stability of Esomeprazole in Dried Blood Spot Sample Using High Performance Liquid Chromatography-Photodiode Array

Yahdiana Harahap; Anja Tamabri; Vicha Vicha; Herman Suryadi; Sunarsih Sunarsih; Callista Andinie Mulyadi

doi:10.22146/ijc.42404

Pharmacokinetic Study and Incurred Sample Stability of Esomeprazole in Dried Blood Spot Sample Using High Performance Liquid Chromatography-Photodiode Array

https://doi.org/10.22146/ijc.42404

Yahdiana Harahap^(1*), Anja Tamabri⁽²⁾, Vicha Vicha⁽³⁾, Herman Suryadi⁽⁴⁾, Sunarsih Sunarsih⁽⁵⁾, Callista Andinie Mulyadi⁽⁶⁾

(1) Faculty of Pharmacy, Universitas Indonesia, Depok 16424, West Java, Indonesia
(2) Faculty of Pharmacy, Universitas Indonesia, Depok 16424, West Java, Indonesia
(3) Faculty of Pharmacy, Universitas Indonesia, Depok 16424, West Java, Indonesia
(4) Faculty of Pharmacy, Universitas Indonesia, Depok 16424, West Java, Indonesia
(5) Dea Medika Clinic, Jl. Bina Marga No. 7, Gunung Putri, Bogor 16961, West Java, Indonesia
(6) Faculty of Pharmacy, Universitas Indonesia, Depok 16424, West Java, Indonesia
(*) Corresponding Author

Abstract

In the past years, Esomeprazole (EMP) was analyzed in human plasma samples, which still has stability issues; thus, the new biosampling technique known as Dried Blood Spot (DBS) might solve the issue. This research aims to evaluate the incurred sample stability of esomeprazole in dried blood spot using high performance liquid chromatography-photodiode array with lansoprazole as an internal standard. The analytical separation was performed on a C-18 column (Waters, Sunfire™ 5 μm; 250 × 4.6 mm) at 40 °C. The mobile phase used was acetonitrile–phosphate buffer pH 7.6 (40:60% v/v) with a flow rate of 1.00 mL/min; and was detected at 300 nm. The analyte was extracted from dried blood spot by methanol. Incurred sample stability was evaluated from 6 healthy subjects on day 0, 7, 14, and 28, respectively. This method was linear in the range concentration of 70–1400 ng/mL with r > 0.98. Pharmacokinetic study shows that the average of AUC_0–t of EMP in the DBS sample was 1765.41 ngh/mL. The highest percent difference value of esomeprazole’s incurred samples stability on day 7, 14, and 28 from 6 healthy subjects were 9.81%. This result fulfilled the acceptance criteria, which is the percent difference should not be greater than 20%, and 67% of total samples have to fulfill the criteria. The incurred sample stability result showed that esomeprazole was stable in the DBS sample at least until 28 days with the highest value of percent difference is 9.81%.

Keywords

dried blood spot; esomeprazole; lansoprazole; HPLC; incurred sample

Full Text:

Full Text PDF

References

[1] Food and Drug Administration, 2014, NEXIUM (esomeprazole magnesium) delayed-release capsules, for oral use, Reference ID: 3675799, Food and Drug Administration, U.S. Department of Health and Human Services, USA.

[2] Xu, Y., Fang, W., Zeng, W., Leijen, S., and Woolf, E.J., 2012, Evaluation of dried blood spot (DBS) technology versus plasma analysis for the determination of MK-1775 by HILIC-MS/MS in support of clinical studies, Anal. Bioanal. Chem., 404 (10), 3037–3048.

[3] Li, W., and Lee, M.S., 2014, Dried Blood Spots: Applications and Techniques, John Wiley & Sons, Inc., Hoboken, New York.

[4] Zakaria, R., Allen, K.J., Koplin, J.J., Roche, P., and Greaves, R.F., 2016, Advantages and challenges of dried blood spot analysis by mass spectrometry across the total testing process, EJIFCC, 27 (4), 288–317.

[5] Sharma, A., Jaiswal, S., Shukla, M., and Lal, J., 2014, Dried blood spots: Concepts, present status, and future perspectives in bioanalysis, Drug Test. Anal., 6 (5), 399–414.

[6] Hasselgren, G., Hassan-Alin, M., Andersson, T., Claar-Nilsson, C., and Röhss, K., 2001, Pharmacokinetic study of esomeprazol in the elderly, Clin. Pharmacokinet., 40 (2), 145–150.

[7] Harahap, Y., Baskara, A.E., and Harmita, 2017, Method validation of esomeprazol analysis in human plasma using high performance liquid chromatography–photodiode array, J. Young Pharm., 9 (Suppl. 1), s24–s28.

[8] Wen, Z., Huang, Y., Behler, N., Bambal, R., Bhoopathy, S., and Owen, A., 2010, Determination of red blood cell partitioning and whole blood to plasma ratio using human, rat, and mouse blood: Methods, model-compounds, and specific differences, Absorption Systems, Exton, Pennsylvania, USA.

[9] Reddy, P., Sait, S., Vasudevmurthy, G., Vishwanath, B., Prasad, V., and Reddy, S.J., 2011, Stability indicating simultaneous estimation of assay method for naproxen and esomeprazole in pharmaceutical formulations by RP-HPLC, Der Pharma Chemica, 3 (6), 553–564.

[10] Lowes, S., LeLacheur, R., Shoup, R., Garofolo, F., Dumont, I., Martinez, S., Zimmer, J., Caturla, M.C., Couerbe, P., Awaiye, K., Fatmi, S., Farmen, R., Sheldon, C., Bower, J., Fiscella, M., Fast, D., Cape, S., Hulse, J., Kamerud, J., Zhang, T., Pasas-Farmer, S., Garofolo, W., Moussallie, M., Rocci, M., Allinson, J., Gouty, D., Buonarati, M., Boudreau, N., Pellerin, B., Lin, J., Xu, A., Hayes, R., Bouhajib, M., Stipancic, M., Nicholson, R., Nehls, C., Warren, M., Karnik, S., Houghton, R., Stovold, C., Reuschel, S., Cojocaru, L., Marcelletti, J., Fang, X., Smith, I., and Watson, A., 2014, Recommendations on incurred sample stability (ISS) by GCC, Bioanalysis, 6 (18), 2385–2390.

[11] Es’haghi, Z., 2011, “Photodiode array detection in clinical applications: Quantitative analyte assay advantages, limitations, and disadvantages” in Photodiodes—Communications, Bio-Sensings, Measurements and High-Energy Physics, Chapter 9, Eds. Shi, J.W., InTechOpen, New York.

[12] Committee for Medicinal Products for Human Use (CHMP), 2011, Guideline on bioanalytical method validation, European Medicines Agency London, UK.

[13] United States Food and Drug Administration, 2013, Guidance for industry. Bioanalytical method validation, U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), and Center for Veterinary Medicine (CVM), USA.

[14] Koster, R.A., Greijdanus, B., Alffenaar, J.W., and Touw, D.J., 2015, Dried blood spot analysis of creatinine with LC-MS/MS in addition to immunosuppressants analysis, Anal. Bioanal. Chem., 407 (6), 1585–1594.

[15] Hielscher Ultrasound Technology, 2018, Probe-type sonication vs. ultrasonic bath: An efficiency comparison, https://www.hielscher.com/probe-type-sonication-vs-ultrasonic-bath-an-efficiency-comparison.html, accessed on 7 December 2018.

[16] Lad, R., 2010, Validation of individual quantitative methods for determination of cytochrome P450 probe substrates in human dried blood spots with KCKT–MS/MS, Bioanalysis, 2 (11), 1849–1861.

[17] Wilhelm, A.J., den Burger, J.C., and Swart, E.L., 2014, Therapeutic drug monitoring by dried blood spot: Progress to date and future directions, Clin. Pharmacokinet., 53 (11), 961–973.

[18] Committee for Medicinal Products for Human Use (CHMP), 2010, Guideline on the investigation of bioequivalence (Rev. 1), European Medicines Agency, London, United Kingdom.

[19] Déglon, J., Thomas, A., Mangin, P., and Staub, C., 2011, Direct analysis of dried blood spots coupled with mass spectrometry: Concepts and biomedical applications, Anal. Bioanal. Chem., 402 (8), 2485–2498.

[20] Chunduri, R.H.B., and Dannana, G.S., 2016, Development and validation of a high throughput UPLC–MS/MS method for simultaneous quantification of esomeprazol, rabeprazole, and levosulpiride in human plasma, J. Pharm. Anal., 6 (3), 190–198.

DOI: https://doi.org/10.22146/ijc.42404