Analysis of Naproxen in Rabbit Plasma by GC-MS Method

Yıl 2022, Cilt: 12 Sayı: 3, 1635 - 1643, 01.09.2022

Bilal Yilmaz

https://doi.org/10.21597/jist.1083520

Öz

Naproxen is one of the most used drugs today. Therefore, it is important to develop new and simple methods for the determination of naproxen. The goal of this research is to develop a gas chromatography-mass spectrometry method for analyzing naproxen levels in rabbit plasma and apply this method to the pharmacokinetic study. The liquid-liquid extraction technique was used to prepare blood samples from rabbits. Separation of naproxen was achieved on an HP-5 MS column. The method’s calibration curve was plotted between 0.1 and 5.0 μg mL-1. The accuracy results were better than 2.18% and the precision results were less than 4.17% in rabbit plasma for naproxen. The method had recovery values >94.2% for all samples in rabbit plasma. In addition, the validated method was used to study naproxen pharmacokinetics in rabbits. The maximum naproxen plasma concentration is 42.1±4.243 μg mL-1. The duration to attain the greatest naproxen concentration and the area under the curve from (AUC0-16 h) were 1.50±0.196 h and 566.3±41.72 μg mL-1 h.

Anahtar Kelimeler

GC-MS, extraction, naproxen, pharmacokinetic, rabbit

Teşekkür

The author would like to thank Vedat Akba (Criminal Police Laboratory, 25060, Erzurum, Turkey) for their help in GC-MS analyses. The author also wishes to thank Semih Yilmaz for expert advice on the use of English.

Tavşan Plazmasında Naproksenin GC-MS Yöntemi ile Analizi

Öz

Naproksen günümüzde en çok kullanılan ilaçlardan biridir. Bu nedenle, naproksen tayini için
yeni ve basit yöntemlerin geliştirilmesi önemlidir. Bu çalışmanın amacı tavşan plazmasında naproksenin
analizi için bir gaz kromatografisi-kütle spektrometri yöntem geliştirmek ve farmakokinetik çalışmaya
uygulamaktır. Tavşan kan örnekleri sıvı-sıvı ekstraksiyon yöntemi ile hazırlanmıştır. Naproksenin
ayırımı HP-5 MS kolon ile yapılmıştır. Yöntemin kalibrasyon eğrisi 0.1 ve 5.0 μg mL-1 arasında çizildi.
Tavşan plazmasında naproksenin kesinlik sonuçları %4.17’den küçüktü ve doğruluk sonuçları
%2.18’den daha iyiydi. Yöntemin tavşan plazmasındaki tüm örnekler için geri kazanım değerleri
>%94.2’tür. Ayrıca, tavşanlarda naproksenin farmakokinetiğini incelemek için valide edilen yöntem
uygulanmıştır. Maksimum naproksen plazma konsantrasyonu 42.1±4.243 μg mL-1 idi. Naproksenin
maksimum konsantrasyona ulaşma süresi ve eğrinin altındaki alan (AUC0-16 h) sırasıyla 1.50±0.196 h ve
566.3±41.72 μg mL-1 idi.

Anahtar Kelimeler

GC-MS, ekstraksiyon, naproksen, farmakokinetik, tavşan

Kaynakça

• Aresta A, Palmisano F, Zambonin CG, 2005. Determination of naproxen in human urine by solid-phase microextraction coupled to liquid chromatography. J Pharm Biomed Anal 39:643-647.
• Camilo K, Foley JP, 2021. Simultaneous achiral/chiral HPLC separation of ketoprofen, ibuprofen, flurbiprofen, and naproxen. Chromatographia, 84(7):1-9.
• Goktas EF, Kabil E, Arıoz F, 2020. Quantification and validation of nine nonsteroidal anti-inflammatory drugs in equine urine using gas chromatography-mass spectrometry for doping control. Drug Test Anal, 12:1065-1077.
• Guidance for Industry, Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, MD, 2001.
• Hamid MHM, Elsaman T, 2017. A stability-indicating RP-HPLC-UV method for determination and chemical hydrolysis study of a novel naproxen prodrug. J Chem, 1-10.
• Hirai T, Matsumoto S, Kishi I, 1997. Simultaneous analysis of several non-steroidal anti-inflammatory drugs in human urine by high-performance liquid chromatography with normal solid-phase extraction. J Chromatogr Biomed Appl, 692:375-388.
• Hlozek T, Bursova M, Cabala R, 2014. Fast ibuprofen, ketoprofen and naproxen simultaneous determination in human serum for clinical toxicology by GC-FID. Clin Biochem, 47(15):109-111.
• HsuYH, Liou YB, Lee JA, Chen CY, Wu AB, 2006. Assay of naproxen by high-performance liquid chromatography and identification of its photoproducts by LC-ESI MS. Biomed Chromatogr, 20(8):787-93.
• Krokos A, Tsakelidou E, Michopoulou E, Raikos N, Theodoridis G, Gika H, 2018. NSAIDs determination in human serum by GC-MS. Separations, 5(3):37-50.
• Mikami E, Goto T, Ohno T, Matsumoto H, Nishida M, 2000. 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, 23: 917-925.
• Muneer S, Muhammad IN, Abrar MA, Munir I, Kaukab I, Sagheer A, Zafar H, Sultana K, 2017. High performance liquid chromatographic determination of naproxen in prepared pharmaceutical dosage form and human plasma and its application to pharmacokinetic study. J Chromatogr Sep Tech, 8:369-374.
• Muthal AP, Snow NH, 2016. Solid-phase microextraction comprehensive two-dimensional gas chromatography time of flight-mass spectrometry (SPMEGC×GC-TOF-MS) of non-steroidal anti-inflammatory drugs from water. Scientia Chromatographica, 8(1):25-33.
• Navalon A, Blanc R, Del Olmo M, Vilchez JL, 1999. Simultaneous determination of naproxen, salicylic acid and acetylsalicylic acid by spectrofluorimetry using partial least-squares (PLS) multivariate calibration. Talanta, 48(2):469-75.
• Pietruk M, Jedziniak P, Olejnik M, 2021. LC-MS/MS Determination of 21 non-steroidal anti-inflammatory drugs residues in animal milk and muscles. Molecules, 26 (19): 5892-5602.
• Pushpa E, Sailaja B, 2020. Stability indicating RP-HPLC method development and validation for the determination of naproxen sodium in bulk drug and tablet dosage form. Int J Pharm Qual Assur, 11(4):525-529.
• Satterwhite JH, Boudinot FD, 1988. High-performance liquid chromatographic determination of ketoprofen and naproxen in rat plasma. J Chromatogr Biomed Appl, 431:444-449.
• Shimek JL, Rao NG, Khalil SK, 1982. An isocratic high-pressure liquid chromatographic determination of naproxen and desmethylnaproxen in human plasma. J Pharm Sci, 71:436-439.
• Sondnara N, Sawathee S, Atipairin A, 2018. Stability-indicating HPLC method for determination of naproxen in an extemporaneous suspension. Research J Pharm and Tech, 11(10):4332-4338.
• Sultan M, Stecher G, Stöggl WM, Bakry R, Zaborski P, Huck CW, El Kousy NM, Bonn GK, 2005. 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 micro HPLC. Curr Med Chem, 12:573-588.
• Upton RA, Buskin JN, Guentert TW, Williams RL, Riegelman S, 1980. Convenient and sensitive high-performance liquid chromatography assay for ketoprofen, naproxen and other allied drugs in plasma or urine. J Chromatogr, 190:119-128.
• Vittal SP, Rao SV, Ramakrishna K, 2019. Stability indicating RP-HPLC method for simultaneous determination of potential impurities of sumatriptan and naproxen sodium in fixed dose combination. Rasayan J Chem, 12:1601-1612.
• Vree TB, Van Den Biggelaar-Martea M, Verwey-van Wissen CP, 1992. 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 Chromatogr Biomed Appl, 578:239-249.
• Westerlund D, Theodorsen A, Jaksch Y, 1979. Bioanalysis of naproxen by high performance reversed phase liquid chromatography with photometric and fluorimetric detection. J Liq Chromatogr Relat Technol, 2:969-1001.
• Yilmaz B, Asci A, Palabiyik SS, 2010. Determination of ibuprofen in rabbit plasma by high-performance liquid chromatography. Kafkas Univ Vet Fak Derg, 16(6):1005-1010.
• Yuan X, Li X, Guo P, Zhao L, 2018. Simultaneous enantiomeric analysis of chiral non-steroidal anti-inflammatory drugs in water, river sediment and sludge by chiral liquid chromatography-tandem mass spectrometry. Anal Methods, 10:4404-4413.