Direct Injection Microemulsion HPLC Method for Simultaneous Determination of Morphine, Tramadol and Lornoxicam in Biological Fluids Using Monolithic Column

Author(s): Fathalla Belal, Mahmoud A. Omar, Sayed M. Derayea, Sahar Zayed, Mohamed A. Hammad, Safaa F. Saleh, Hassan A. Alhazmi*, Mohammed Al Bratty

Journal Name: Current Pharmaceutical Analysis

Volume 16 , Issue 8 , 2020


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Graphical Abstract:


Abstract:

Objective: A rapid and environmental friendly microemulsion liquid chromatographic method was developed for simultaneous quantification of morphine (MOR), tramadol (TRA) and lornoxicam (LOR) in biological fluids.

Methods: Microemulsion used in this study was an aqueous solution containing sodium dodecyl sulfate (0.12 M), n-propanol (10%), ethyl acetate (0.75%), tri-ethyl amine (0.3%), orthophosphoric acid (0.15 %) and the pH was adjusted to 3.0 with orthophosphoric acid. Chromatographic separation was carried out on a monolithic C18 column and a mobile phase flow rate of 1.0 mL min−1 was applied throughout the analysis. The data was monitored using UV-detection mode at a wavelength of 220 nm.

Results: Under the optimized conditions, all the studied drugs were well resolved and completely eluted within 6 min. The proposed method was linear over the concentration ranges of 0.5−100, 0.75−125 and 0.25−50 μg mL−1; limits of detection of 0.074, 0.086 and 0.056 μgmL−1 and limits of quantification of 0.21, 0.28 and 0.12 were recorded for TRA, LOR, and MOR, respectively. The developed method was fully validated according to the ICH guidelines. The method was successfully utilized to estimate the tested analytes in plasma and urine samples, which were directly injected into the chromatographic system after suitable dilution with the microemulsion.

Conclusion: The developed method is considered to be very efficient to analyze the cited drugs in different biological fluids with low running costs and short analysis time.

Keywords: Microemulsion liquid chromatography, morphine, lornoxicam, tramadol, biological fluids, direct injection.

[1]
Jin, F.; Chung, F. Multimodal analgesia for postoperative pain control. J. Clin. Anesth., 2001, 13(7), 524-539.
[http://dx.doi.org/10.1016/S0952-8180(01)00320-8] [PMID: 11704453]
[2]
Kim, Y.H.; Ji, H.Y.; Park, E.S.; Chae, S.W.; Lee, H.S. Liquid chromatography-electrospray ionization tandem mass spectrometric determination of lornoxicam in human plasma. Arch. Pharm. Res., 2007, 30(7), 905-910.
[http://dx.doi.org/10.1007/BF02978844] [PMID: 17703745]
[3]
Nakamura, A.; Nakashima, M.N.; Wada, M.; Nakashima, K. Semi-micro column HPLC of three oxicam non-steroidal anti-Inflammatory drugs in human blood. Bunseki Kagaku, 2005, 54, 755-760.
[http://dx.doi.org/10.2116/bunsekikagaku.54.755]
[4]
Radhofer-Welte, S.; Dittrich, P. Determination of the novel non-steroidal anti-inflammatory drug lornoxicam and its main metabolite in plasma and synovial fluid. J. Chromatogr. B Biomed. Sci. Appl., 1998, 707(1-2), 151-159.
[http://dx.doi.org/10.1016/S0378-4347(97)00597-5] [PMID: 9613944]
[5]
Meng, Q.C.; Cepeda, M.S.; Kramer, T.; Zou, H.; Matoka, D.J.; Farrar, J. High-performance liquid chromatographic determination of morphine and its 3- and 6-glucuronide metabolites by two-step solid-phase extraction. J. Chromatogr. B Biomed. Sci. Appl., 2000, 742(1), 115-123.
[http://dx.doi.org/10.1016/S0378-4347(00)00146-8] [PMID: 10892590]
[6]
Vlase, L.; Leucuta, S.E.; Imre, S. Determination of tramadol and O-desmethyltramadol in human plasma by high-performance liquid chromatography with mass spectrometry detection. Talanta, 2008, 75(4), 1104-1109.
[http://dx.doi.org/10.1016/j.talanta.2008.01.006] [PMID: 18585190]
[7]
Ardakani, Y.H.; Mehvar, R.; Foroumadi, A.; Rouini, M.R. Enantioselective determination of tramadol and its main phase I metabolites in human plasma by high-performance liquid chromatography. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2008, 864(1-2), 109-115.
[http://dx.doi.org/10.1016/j.jchromb.2008.01.038] [PMID: 18282749]
[8]
Coles, R.; Kushnir, M.M.; Nelson, G.J.; McMillin, G.A.; Urry, F.M. Simultaneous determination of codeine, morphine, hydrocodone, hydromorphone, oxycodone, and 6-acetylmorphine in urine, serum, plasma, whole blood, and meconium by LC-MS-MS. J. Anal. Toxicol., 2007, 31(1), 1-14.
[http://dx.doi.org/10.1093/jat/31.1.1] [PMID: 17389078]
[9]
Ghassabian, S.; Moosavi, S.M.; Valero, Y.G.; Shekar, K.; Fraser, J.F.; Smith, M.T. High-throughput assay for simultaneous quantification of the plasma concentrations of morphine, fentanyl, midazolam and their major metabolites using automated SPE coupled to LC-MS/MS. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2012, 903, 126-133.
[http://dx.doi.org/10.1016/j.jchromb.2012.07.005] [PMID: 22841553]
[10]
Chen, F.; Fang, B.; Ding, J.L.P.; Shi, X.; Dong, M. Simultaneous determination of morphine, tramadol, fentanyl and lornoxicam in analgesic mixture samples by high perfor-mance liquid chromatography Chinese Med., 2011, (8)
[11]
EL-Sherbiny. D.T.M.; El-Ashry, S.M.; Mustafa, M.A.; El-Emam, A.A.; Hansen, S.H. Evaluation of the use of microemulsions as eluents in high-performance liquid chromatography. J. Sep. Sci., 2003, 26(6-7), 503-509.
[http://dx.doi.org/10.1002/jssc.200390067]
[12]
El-Sherbiny, D.T.; El-Enany, N.; Belal, F.F.; Hansen, S.H. Simultaneous determination of loratadine and desloratadine in pharmaceutical preparations using liquid chromatography with a microemulsion as eluent. J. Pharm. Biomed. Anal., 2007, 43(4), 1236-1242.
[http://dx.doi.org/10.1016/j.jpba.2006.10.027] [PMID: 17126519]
[13]
Walash, M.I.; Belal, F.; El-Enany, N.; Abdelal, A. Microemulsion liquid chromatographic determination of nicardipine hydrochloride in pharmaceutical preparations and biological fluids. Application to stability studies. J. Liq. Chromatogr. Relat. Technol., 2007, 30(8), 1015-1034.
[http://dx.doi.org/10.1080/10826070601128394]
[14]
Althanyan, M.S.; Assi, K.H.; Clark, B.J.; Hanaee, J. Microemulsion high performance liquid chromatography (MELC) method for the determination of terbutaline in pharmaceutical preparation. J. Pharm. Biomed. Anal., 2011, 55(3), 397-402.
[http://dx.doi.org/10.1016/j.jpba.2011.01.027] [PMID: 21371845]
[15]
McEvoy, E.; Donegan, S.; Power, J.; Altria, K. Optimisation and validation of a rapid and efficient microemulsion liquid chromatographic (MELC) method for the determination of paracetamol (acetaminophen) content in a suppository formulation. J. Pharm. Biomed. Anal., 2007, 44(1), 137-143.
[http://dx.doi.org/10.1016/j.jpba.2007.02.025] [PMID: 17383842]
[16]
Peng, L.Q.; Cao, J.; Du, L.J.; Zhang, Q.D.; Shi, Y.T.; Xu, J.J. Analysis of phenolic acids by ionic liquid-in-water microemulsion liquid chromatography coupled with ultraviolet and electrochemical detector. J. Chromatogr. A, 2017, 1499, 132-139.
[http://dx.doi.org/10.1016/j.chroma.2017.03.086] [PMID: 28390669]
[17]
Hernandez, M.J.M.; Alvarez-coque, M.C.G. Solute–mobile phase and solute–stationary phase interactions in micellar liquid chromatography. A review. Analyst (Lond.), 1992, 117(5), 831-837.
[http://dx.doi.org/10.1039/AN9921700831]
[18]
Kaler, E.W.; Prager, S. A model of dynamic scattering by microemulsions. J. Colloid Interface Sci., 1982, 86(2), 359-369.
[http://dx.doi.org/10.1016/0021-9797(82)90081-9]
[19]
Ryan, R.; Donegan, S.; Power, J.; McEvoy, E.; Altria, K. Microemulsion HPLC. LC GC Eur., 2008, 502-513.
[20]
Ali, I.; Gaitonde, V.D.; Aboul-Enein, H.Y. Monolithic silica stationary phases in liquid chromatography. J. Chromatogr. Sci., 2009, 47(6), 432-442.
[http://dx.doi.org/10.1093/chromsci/47.6.432] [PMID: 19555548]
[21]
Hadad, G.M.; Mahmoud, W.M.M. The use of a monolithic column to improve the simultaneous determination of caffeine, paracetamol, pseudoephedrine, aspirin, dextromethorphan, chlorpheniramine in pharmaceutical formulations by HPLC – A comparison with a conventional reversed-phase silica-based column. J. Liq. Chromatogr. Relat. Technol., 2011, 34, 2516-2532.
[http://dx.doi.org/10.1080/10826076.2011.591031]
[22]
El-Sherbiny, D.T.; Eid, M.I.; El-Wasseef, D.R.; Al-Ashan, R.M.; Belal, F. Analysis of flunarizine in the presence of some of its degradation products using micellar liquid chromatography (MLC) or microemulsion liquid chromatography (MELC)--application to dosage forms. J. Sep. Sci., 2005, 28(2), 197-202.
[http://dx.doi.org/10.1002/jssc.200401830] [PMID: 15754830]
[23]
Marsh, A.; Clark, B.; Altria, K. Oil-in-water microemulsion high performance liquid chromatographic analysis of pharmaceuticals. Chromatographia, 2004, 59(9-10), 531-542.
[http://dx.doi.org/10.1365/s10337-004-0262-4]
[24]
Malenovic, A.; Ivanovic, D.; Medenica, M.; Jancic, B.; Markovic, S. Retention modelling in liquid chromatographic separation of simvastatin and six impurities using a microemulsion as eluent. J. Sep. Sci., 2004, 27(13), 1087-1092.
[http://dx.doi.org/10.1002/jssc.200401748] [PMID: 15495410]
[25]
Jancic, B.; Ivanovic, D.; Medenica, M.; Malenovic, A.; Dimkovic, N. Development of liquid chromatographic method for fosinoprilat determination in human plasma using microemulsion as eluent. J. Chromatogr. A, 2005, 1088(1-2), 187-192.
[http://dx.doi.org/10.1016/j.chroma.2005.05.038] [PMID: 16130750]
[26]
Validation of Analytical Procedures. Text and Methodology. in: International Conference on Harmonization 2005.http://www.ipqpubs.com/wpcontent/uploads/2011/09/Q2_R1__Guideline.pdf


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Article Details

VOLUME: 16
ISSUE: 8
Year: 2020
Published on: 27 September, 2020
Page: [1148 - 1156]
Pages: 9
DOI: 10.2174/1573412915666190617172144
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