Determination of Naproxen using derivatization with MSTFA in pharmaceutical preparations by GC-MS method

Year 2024, , 1 - 5, 30.06.2024

Bilal Yılmaz , Ömer Turan , Semih Yılmaz , Yücel Kadıoğlu

https://doi.org/10.5281/zenodo.12542881

Abstract

Bu çalışma, naproksenin türetilmesi için N-metil-N-(trimetilsilil) trifloroasetamidin kullanımını ve farmasötik preparasyonlarda naproksenin saptanması için GC-MS yönteminin kullanımını rapor etmektedir. GC-MS yönteminin doğrusallığı 0.5-12 µg/mL konsantrasyon aralığında kanıtlanmıştır. Gün içi ve günler arası bağıl standart sapma sırasıyla %1.20 ve %1.73'ten azdı. GC-MS yöntemi için tespit ve miktar belirleme limitleri 0.05 ve 0.15 µg/mL olarak belirlendi. Geliştirilen yöntem, Aleve adı verilen farmasötik bir preparatın tabletlerini analiz için kullanıldı. Seçilen test koşullarında, tablet yardımcı maddeleri herhangi bir etkileşime neden olmadı.

Keywords

Naproxen, GC-MS, Derivatization, Validation

Ethical Statement

Since it is a drug analysis performed under in vitro conditions, ethics committee approval is not required

References

• 1. Boynton CS, Dick CF, Mayor GH. NSAIDs: An Overview. J Clin Pharmacol. 1988;28(6):512-517. doi:10.1002/j.1552- 4604.1988.tb03170.x
• 2. Sun Y, Zhang Z, Xi Z, Shi Z. Determination of naproxen in human urine by high-performance liquid chromatography with direct electrogenerated chemiluminescence detection. Talanta. 2009;79(3):676-680. doi:10.1016/j.talanta.2009.04.048
• 3. Aresta A, Palmisano F, Zambonin CG. Determination of naproxen in human urine by solid-phase microextraction coupled to liquid chromatography. J Pharm Biomed Anal. 2005;39(3-4):643-647. doi:10.1016/j.jpba.2005.04.017
• 4. Kovacevic L, Bernstein J, Valentini RP, Imam A, Gupta N, Mattoo TK. Renal papillary necrosis induced by naproxen. Pediatr Nephrol. 2003;18(8):826-829. doi:10.1007/s00467-003-1167-4
• 5. Van Loenhout JWA, Van Ginneken C a. M, Ketelaars HCJ, Kimenai PM, Tan Y, Gribnau FWJ. A High-Performance Liquid Chromatographic Method for the Quantitative Determination of Naproxen and Des-Methyl-Naproxen in Biological Samples. J Liq Chromatogr. 1982;5(3):549-561. doi:10.1080/01483918208066913
• 6. Zakeri-Milani P, Barzegar-Jalali M, Tajerzadeh H, Azarmi Y, Valizadeh H. Simultaneous determination of naproxen, ketoprofen and phenol red in samples from rat intestinal permeability studies: HPLC method development and validation. J Pharm Biomed Anal. 2005;39(3-4):624-630. doi:10.1016/j.jpba.2005.04.008
• 7. Slattery JT, Levy G. Determination of naproxen and its desmethyl metabolite in human plasma or serum by high performance liquid chromatography. Clin Biochem. 1979;12(3):100-103. doi:10.1016/s0009-9120(79)80075-2
• 8. Satterwhite JH, Boudinot FD. High-performance liquid chromatographic determination of ketoprofen and naproxen in rat plasma. J Chromatogr B. 1988;431:444-449. doi:10.1016/s0378-4347(00)83116-3
• 9. Upton RA, Buskin JN, Guentert TW, Williams RL, Riegelman S. Convenient and sensitive high-performance liquid chromatography assay for ketoprofen, naproxen and other allied drugs in plasma or urine. J Chromatogr A. 1980;190(1):119-128. doi:10.1016/s0021-9673(00)85518-1
• 10. Vree TB, Van Den Biggelaar-Martea M, Verwey-van Wissen CPWGM. Determination of naproxen and its metabolite O￾desmethylnaproxen with their acyl glucuronides in human plasma and urine by means of direct gradient high￾performance liquid chromatography. J Chromatography B. 1992;578(2):239-249. doi:10.1016/0378-4347(92)80422-m
• 11. Hirai T, Matsumoto S, Kishi I. Simultaneous analysis of several non-steroidal anti-inflammatory drugs in human urine by high-performance liquid chromatography with normal solid-phase extraction. J Chromatography B.1997;692(2):375-388. doi:10.1016/s0378-4347(96)00509-9
• 12. Shimek JL, Rao NGS, Wahba Khalil K. An isocratic high-pressure liquid chromatographic determination of naproxen and desmethylnaproxen in human plasma. J Pharm Sci. 1982;71(4):436-439. doi:10.1002/jps.2600710415
• 13. Burgoyne RF, Brown PR, Kaplan SR. The simultaneous assay of naproxen and salicylic acid in serum using high pressure liquid chromatography. J Liq Chromatogr. 1980;3(1):101-111. doi:10.1080/01483918008060157
• 14. Westerlund D, Theodorsen A, Jaksch Y. Bioanalysis of Naproxen by High Performance Reversed Phase Liquid Chromatography with Photometric and Fluorimetric Detection. J Liq Chromatogr. 1979;2(7):969-1001. doi:10.1080/01483917908060119
• 15. Tashtoush, B.M., Al-Taani B.M.; HPLC determination of naproxen in plasma, Pharmazie, (2003);58:614-615.
• 16. Mikami E, Goto T, Ohno T, Matsumoto H, Nishida M. Simultaneous analysis of naproxen, nabumetone and its major metabolite 6-methoxy-2-naphthylacetic acid in pharmaceuticals and human urine by high-performance liquid chromatography. J Pharm Biomed Anal. 2000;23(5):917-925. doi:10.1016/s0731-7085(00)00365-4
• 17. Sultan M, Stecher G, Stoggl W, et al. Sample pretreatment and determination of non steroidal anti-inflammatory drugs (NSAIDs) in pharmaceutical formulations and biological samples (blood, plasma, erythrocytes) by HPLC￾UV-MS and HPLC. Curr Med Chem. 2005;12(5):573-588. doi:10.2174/0929867310504050573
• 18. Miksa IR, Cummings MR, Poppenga RH. Multi-residue determination of anti-inflammatory analgesics in sera by liquid chromatography-mass spectrometry. J Anal Toxicol. 2005;29(2):95-104. doi:10.1093/jat/29.2.95
• 19. Larsen NE, Marinelli K. Mass fragmentographic quantification of naproxen in human plasma. J Chromatography B. 1981;222(3):482-485. doi:10.1016/s0378-4347(00)84151-1
• 20. Wan SH, Matin SB. Quantitative gas-liquid chromatographic analysis of naproxen, 6-O-desmethyl￾naproxen and their conjugates in urine. J Chromatography A. 1979;170(2):473-478. doi:10.1016/s0021-9673(00)95480-3
• 21. Weber SS, Bankhurst AD, Mroszczak E, Ding TL. Effect of mylanta® on naproxen bioavailability. Ther Drug Monit. 1981;3(1):75-84. doi:10.1097/00007691-198101000-00010
• 22. Desager JP, Vanderbist M, Harvengt C. Naproxen plasma levels in volunteers after single‐dose administration by oral and rectal routes. J Clin Pharmacol. 1976;16(4):189-193. doi:10.1002/j.1552-4604.1976.tb01516.x
• 23. Bouchafra H, Orche AE, Khabbaz CE, Cheikh A, Faouzi MEA, Cherrah Y, Zarayby L, Hirr A. Determination and validation of tiaprofenic acid in human plasma: A detailed LC-MS/MS￾based analysis following ICH M10 guidelines and the accuracy profile approach. Research Square. 2024;1-16. doi: ttps://doi.org/10.21203/rs.3.rs-3848449/v1
• 24. Yilmaz B, Arslan S, Akba V. Gas chromatography–mass spectrometry method for determination of metoprolol in the patients with hypertension. Talanta. 2009;80(1):346-351. doi:10.1016/j.talanta.2009.06.079
• 25. Yilmaz B. GC–MS determination of diclofenac in human plasma. Chromatographia. 2010;71(5-6):549-551. doi:10.1365/s10337-010-1479-z
• 26. Yilmaz B. Determination of Atenolol in Pharmaceutical Preparations by Gas Chromatography with Flame Ionization and Mass Spectrometric Detection. Anal Lett. 2010;43(15):2311-2317. doi: 10.1080/00032711003717414
• 27. Way BA, Wilhite TR, Smith CH, Landt M. Measurement of plasma ibuprofen by gas chromatography-mass spectrometry. J Clin Lab Anal. 1997;11(6):336-339. http://dx.doi.org/10.1002/(sici)1098-2825(1997)11:6<336::aid-jcla4>3.0.co;2-3
• 28. Sebők Á, Vasanits-Zsigrai A, Palkó Gy, Záray Gy, Molnár￾Perl I. Identification and quantification of ibuprofen, naproxen, ketoprofen and diclofenac present in waste￾waters, as their trimethylsilyl derivatives, by gas chromatography mass spectrometry. Talanta. 2008;76(3):642-650. doi:10.1016/j.talanta.2008.04.008