The Application of TLC and Densitometry for Quantitative Determination of Meloxicam in Tablets

Author(s): Wioletta Parys, Katarzyna Bober, Alina Pyka-Pająk*, Małgorzata Dołowy.

Journal Name: Current Pharmaceutical Analysis

Volume 15 , Issue 7 , 2019

Become EABM
Become Reviewer

Graphical Abstract:


Abstract:

Background: Meloxicam is as a non-steroidal anti-inflammatory drug that indicates a strong anti-inflammatory, analgesic and antipyretic activity. It is used in the treatment of osteoarthritis arthritis, osteoarthritis and rheumatoid arthritis in the form of various pharmaceutical preparations.

Objective: The aim of the work was an elaboration of chromatographic conditions enabling the complete separation of impurities A and B from meloxicam and also its quantitative determination in tablets with use of TLC combined with densitometry as well as the comparison of the method proposed with that described in the literature by Starek and Krzek.

Methods: The mixture of ethyl acetate: toluene: n-butylamine (2:2:1, v/v/v) was used as a mobile phase. Determination of meloxicam was performed on silica gel and aluminium oxide plates. Chromatographic conditions presented in this work are better than those described by Starek and Krzek.

Results: Linearity of the method for both types of plates was in the range from 1.0 to 5.0 µg/spot. Limit of quantification for silica gel plates was 0.18 µg/spot, while for aluminium oxide plates it was 0.26 µg/spot. Limit of detection has been also specified, 0.06 μg/spot for silica gel plates and 0.08 μg/spot for aluminium oxide plates. The average amount of meloxicam in tablets obtained on silica gel plates was 100.4%, and on the aluminium oxide plates it was 100.3%.

Conclusion: The developed method of determination of meloxicam using thin layer chromatography combined with densitometry turned out to be accurate, precise and specific. It can be successfully applied in quality control of meloxicam.

Keywords: Chromatography, TLC, densitometry, meloxicam, validation, nonsteroidal anti-inflammatory drugs.

[1]
Luger, P.; Daneck, K.; Engel, W.; Trummlitz, G.; Wagner, K. Structure and physicochemical properties of meloxicam, a new NASID. Eur. J. Pharm. Sci., 1996, 4, 175-187.
[2]
Polish Pharmacopeia; Polish Pharmaceutical Society: Warsaw, Poland, 2014.
[3]
Podlewski, J.K.; Chwalibogowska-Podlewska, A. Drugs contemporary treatment; Warsaw: Medical Tribune Poland, 2010.
[4]
Cox, S.; Hayes, J.; Yarbrough, J.; Veiga-Praga, T.; Greenacre, Ch. High-performance liquid chromatography determination of meloxicam and piroxicam with ultraviolet detection. Chromatogr. Res. Int., 2014, 1, 1-7.
[5]
Kimble, B.; Li, K.M.; Govendir, M. Quantitation of meloxicam in the plasma of koals (Phascolarctoscinereus) by improved high performance liquid chromatography. J. Vet. Sci., 2013, 14, 7-14.
[6]
Wasfi, I.A.; Al Ali, W.A.; Agha, B.A.; Kamel, A.M.; Al Biriki, N.A.; Al Neaimi, K.M. The pharmacokinetics and metabolism of meloxicam in camels after intravenous administration. J. Vet. Pharmacol. Ther., 2012, 35, 155-162.
[7]
Starek, M.; Krzek, J. A review of analytical techniques for determination of oxicams, nimesulide and nabumetone. Talanta, 2009, 77, 925-942.
[8]
Starek, M.; Krzek, J. TLC determination of meloxicam in tablets and after acid and alkaline hydrolysis. Acta Pol. Pharm., 2012, 69, 225-235.
[9]
Bebawy, L. Stability-indicating method for the determination of meloxicam and tetracaine hydrochloride in the presence of their degradation products. Spectrosc. Lett., 1998, 31, 797-820.
[10]
Desai, N.; Amin, P. Stability indicating HPTLC determination of meloxicam. Indian J. Pharm. Sci., 2008, 70(5), 644-647.
[11]
Induri, M.; Mantripragada, B.; Yejella, R.; Kunda, P.; Arugula, M.; Boddu, R. Simultaneous quantification of paracetamol and meloxicam in tablets by high performance liquid chromatography. Trop. J. Pharm. Res., 2011, 10(4), 475-481.
[12]
Nalini, K.S.; Madhusmita, S.R.; Podilapu, R.; Sandhya, R.; Induria, D.; Goutam, G. Validation of assay indicating method development of meloxicam in bulk and some its tablet dosage forms by RP-HPLC. Springerplus, 2014, 18(3), 95-101.
[13]
Bandarkar, F.S.; Vavia, P.R. A stability indicating HPLC method for the determination of meloxicam in bulk and commercial formulations. Trop. J. Pharm. Res., 2009, 8(3), 257-264.
[14]
I.C.H, Harmonized Tripartite Guideline. Validation of analytical procedures: text and methodology Q2(R1), Geneva, Switzerland, 2005.http://www.ich.org
[15]
Ferenczi-Fodor, K.; Renger, B.; Végh, Z. The frustrated reviewer– recurrent failures in manuscripts describing validation of quantitative TLC/HPTLC procedures for analysis of pharmaceuticals. J. Planar Chromatogr. Mod. TLC, 2010, 23, 173-179.
[16]
Nomenclature for chromatography (IUPAC Recommendations). Pure Appl. Chem., 1993, 65, 819-872.
[17]
Pyka-Pająk, A.; Dołowy, M.; Parys, W.; Bober, K.; Janikowska, G. A simple and cost-effective TLC-densitometric method for the quantitative determination of acetylsalicylic acid and ascorbic acid in combined effervescent tablets. Molecules, 2018, 23, 3115.
[http://dx.doi.org/10.3390/molecules23123115]
[18]
Konieczka, P.; Namieśnik, J.; Zygmunt, B.; Bulska, E.; Świtaj-Zawadka, A.; Naganowska, A.; Kremer, E.; Rompa, M. Assessment and quality control of analytical results (Polish). Analytical Excellence Center and Environmental Monitoring; CEEEAM: Gdańsk, Poland, 2004.
[19]
The United States Pharmacopeia. The United States Pharmacopeial Convention. Rockville, MD, USA, 2011.


Rights & PermissionsPrintExport Cite as


Article Details

VOLUME: 15
ISSUE: 7
Year: 2019
Page: [785 - 794]
Pages: 10
DOI: 10.2174/1573412915666190212155740
Price: $65

Article Metrics

PDF: 27
HTML: 2
EPUB: 1
PRC: 1