DETERMINATION OF MELOXICAM IN TABLETS BY THIRD DERIVATIVE UV SPECTROPHOTOMETRIC METHOD

Abstract

Objectives: Meloxicam (MEL) is a selective cyclooxygenase inhibitor of enolic acid class drugs with analgesic and antipyretic effects. In this study, an easy, selective, fast, and sensitive third-order derivative spectrophotometric method was developed and validated for the determination of MEL in tablet formulation. Material and Methods: The absorption of MEL in a solution of methanol and 1 M sodium hydroxide (1:1, v/v) mixture was measured using the peak-to-zero method. This solution was found to be the most suitable for determining the drug by third-order derivative spectrometry. The wavelength at which the maximum absorption was achieved in the measurements was 341nm. The developed method has been validated in accordance with the International Conference on Harmonization guidelines (ICH). Results: The linear working range was 1.0 - 14.0 µg/mL. The limit of detection (LOD) and limit of quantification (LOQ) values were 0.22 and 0.75 μg/mL, respectively. The method was validated for linearity, accuracy, precision, recovery, and stability. The developed method was performed for the quantification of MEL in tablets, and the recovery percentage was found to be between 97.50% and 98.12%. Conclusion: The results show that the method is easy, simple, inexpensive, and fast compared to other published methods, in addition to being accurate and sensitive. The proposed method can be used as a very convenient alternative for the determination of MEL in pharmaceutical formulations in routine analysis in quality control.

Keywords

• Third-derivative spectrophotometry
• determination
• meloxicam
• tablets

ÜÇÜNCÜ TÜREV UV SPEKTROFOTOMETRİ İLE TABLETLERDE MELOKSİKAM TAYİNİ

Abstract

Amaç: Meloksikam (MEL), analjezik ve antipiretik etkileri olan seçici bir siklooksijenaz inhibitörü enolik asit sınıfı bir ilaçtır. Bu çalışmada, tablet formülasyonunda meloksikam tayini için kolay, seçici, hızlı ve hassas bir üçüncü dereceden türev spektrofotometrik yöntem geliştirilmiş ve valide edilmiştir. Gereç ve Yöntemler: Üçüncü türev spektrometrisi ile ilaç tayini için en uygun bulunan metanol-1 M sodyum hidroksit (1:1, v/v) çözeltisinde meloksikamın absorpsiyonu pik-sıfır yöntemi ile okundu. Ölçümlerde maksimum absorpsiyonun elde edildiği dalga boyu 341 nm idi. Geliştirilen yöntem, Uluslararası Uyumlaştırma Kılavuzuna (ICH) uygun olarak valide edilmiştir. Bulgular: Doğrusal çalışma aralığı 1,0 - 14,0 μg/mL idi. Gözlenebilme sınırı (LOD) ve tayin sınırı (LOQ) değerleri sırasıyla 0,22 ve 0,75 μg/mL idi. Yöntem, doğrusallık, doğruluk, kesinlik, geri kazanım ve kararlılık açısından doğrulandı. Geliştirilen yöntem tabletlerde meloksikam miktar tayinine uygulanmış ve geri kazanım yüzdesi %97,50 ile %98,12 arasında bulunmuştur. Sonuç: Sonuçlar, yöntemin doğru ve duyarlı olmasının yanı sıra, yayınlanmış diğer yöntemlere göre kolay, basit, ucuz ve hızlı olduğunu göstermektedir. Önerilen yöntem, kalite kontrolde rutin analizlerde farmasötik formülasyonlarda meloksikam tayini için çok uygun bir alternatif olarak kullanılabilir.

Keywords

• Üçüncü türev spektrofotometrisi
• tayin
• meloksikam
• tablet

References

1. Davies NM, Skjodt NM. Clinical pharmacokinetics of meloxicam. Clin Pharmacokinet 1999;36(2):115-26. google scholar
2. Zobdeh F, Eremenko, II, Akan, MA, Tarasov VV, Chubarev VN, Schiöth HB, et al. Pharmacogenetics and Pain Treatment with a Focus on Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Antidepressants: A Systematic Review. Pharmaceutics 2022;14(6):1190. google scholar
3. Xu S, Rouzer, CA, Marnett LJ. Oxicams, a class of nonsteroidal anti-inflammatory drugs and beyond. IUBMB Life 2014;66(12):803-11. google scholar
4. Selesovska R., Hlobenova F, Skopalova J, Cankar P, Jarnkova L, Chylkova J. Electrochemical oxidation of anti-inflammatory drug meloxicam and its determination using boron doped diamond electrode. J Electroanal Chem 2020;858:113758. google scholar
5. Eroğlu ME, Bayraktepe DE, Polat K, Yazan Z. Electro-oxidation mechanism of meloxicam and electrochemical sensing platform based on graphene nanoparticles for its sensing pharmaceutical sample. Curr Pharm Anal 2019;15(4):346-54. google scholar
6. Radi AE, Ghoneim M, Beltagi A. Cathodic adsorptive stripping square-wave voltammetry of the anti-inflammatory drug meloxicam. Chem Pharm Bull 2001 49(10):1257-60. google scholar
7. Bae JW, Kim MJ, Jang CG, Lee SY. Determination of meloxicam in human plasma using a HPLC method with UV detection and its application to a pharmacokinetic study. J Chromatogr B 2007;859(1):69-73. google scholar
8. Liew KB., Loh GO. K, Tan YTF, Peh KK. Improved protein deproteinization method for the determination of meloxicam in human plasma and application in pharmacokinetic study. Biomed Chromatogr 2014;28(12):1782-8. google scholar

9. Tian Y, Wu X, Zhang M, Zhao L, Xiong Z, Qin F. Quantitative determination of meloxicam in dog plasma by high performance liquid chromatography-tandem mass spectrometry and its application in a pharmacokinetic study. Biomed Chromatogr 2018;32(7):e4228. google scholar
10. Miyamoto A, Aoyama T, Matsumoto Y. The measurement of meloxicam and meloxicam metabolites in rat plasma using a high-performance liquid chromatography-ultraviolet spectrophotometry method. Chem Pharm Bull 2017;65(2):121-6. google scholar
11. Sahoo NK, Sahu M, Rao PS, Rani NS, Devi JNV, Ghosh G. Validation of assay indicating method development of meloxicam in bulk and some of its tablet dosage forms by RP-HPLC. Springerplus 2014;3(1):1-6. google scholar
12. Bandarkar FS, Vavia PR. A stability indicating HPLC method for the determination of meloxicam in bulk and commercial formulations. Trop J Pharm Res 2009;8(3):257-64. google scholar
13. Ahmad S, Deepika S, Amol P, Kapil W, Usman MR M. Novel RP-HPLC Method Development and Validation of meloxicam suppository. IJPER 2017;51(4):644-9. google scholar
14. Taha EA, Salama NN, Fattah LESA. Stability-indicating chromatographic methods for the determination of some oxicams. AOAC Int 2004;87(2):366-73. google scholar
15. Vignaduzzo SE., Castellano PM, Kaufman TS. Method development and validation for the simultaneous determination of meloxicam and pridinol mesylate using RP-HPLC and its application in drug formulations. J Pharm Biomed Anal 2008;46(2):219-25. google scholar
16. Induri M, Mantripragada BR, Yejella RP, Kunda PR, Arugula M, Boddu R. Simultaneous quantification of paracetamol and meloxicam in tablets by high performance liquid chromatography. Trop J Pharm Res 2011;10(4):475-81. google scholar
17. Ji HY, Lee HW, Kim YH, Jeong, DW, Lee H S. Simultaneous determination of piroxicam, meloxicam and tenoxicam in human plasma by liquid chromatography with tandem mass spectrometry. J Chromatogr B 2005;826(1-2):214-9. google scholar
18. Zaman M, Murtaza H. Development and validation of RP-HPLC method for simultaneous estimation of tizanidine HCl and meloxicam in bilayer mucoadhesive buccal films. Acta Pol Pharm -Drug Res 2018;75(4):851-9. google scholar
19. Hassan EM. Spectrophotometric and fluorimetric methods for the determination of meloxicam in dosage forms. J Pharm Biomed Anal 2002;27(5):771-7. google scholar
20. Induri M, Mantripragada BR, Yejella RP, Kunda PR, Nannapaneni DT, Boddu R. Dissolution studies and quantification of meloxicam in tablet dosage form by spectrophotometry. Pak J Pharm Sci 2012;25(1):283-7. google scholar
21. Hasan SH, Othman NS, Surchi KM. Development and Validation of a UV-Spectrophotometric Method for Determination of Meloxicam in Bulk and in Tablet Formulations Int J Pharm Sci Res 2015;6(7):1040-5. google scholar
22. Chaudhary KB, Bhardwaj K, Verma G, Kumar P. Validated Analytical Method development for the determination of Meloxicam by UV Spectroscopy in API and Pharmaceutical dosage form. AJPER 2018;7(2):60-9. google scholar
23. Garcla MS, Sânchez-Pedreno C, Albero MI, Martı J. Spectrophotometric methods for determining meloxicam in pharmaceuticals using batch and flow-injection procedures. Eur J Pharm Sci 2000;9(3):311-6. google scholar
24. Abed RI, Hadi H. Determination of meloxicam using direct and indirect flow injection spectrophotometry. Curr Pharm Anal 2021;17(2):254-64. google scholar
25. Mandrescu M, Spac AF, Dorneanu V. Spectrophotometric determination of meloxicam. Rev Chim 2009;60(2):160-3. google scholar
26. Dhandapani B, Eswara MS, Susrutha N, Rama S, Rani S, Sarath T, et al. Spectrophotometric estimation of meloxicam in bulk and its pharmaceutical formulations. Int J Pharm Sci Res 2010;1(4):217-21. google scholar
27. Rao RN, Meena S, Rao AR. An overview of the recent developments in analytical methodologies for determination of COX-2 inhibitors in bulk drugs, pharmaceuticals and biological matrices. J Pharm Biomed Anal 2005;39(3-4):349-63. google scholar
28. Gurupadayya BM, Trinath MN, Shilpa K. Spectrophotometric determination of meloxicam by sodium nitroprusside and 1, 10-phenanthroline reagents in bulk and its pharmaceutical formulation. Indian J Chem Technol 2013;20(3):111-5. google scholar
29. Basu, SK, Mandal S. Spectrophotometric methods for the estimation of meloxicam in dosage forms. Asian J Chem 2009;21(7):5184-8. google scholar
30. Salazar-Rojas D, Intilangelo A, Vignaduzzo SE, Maggio RM. Development and validation of a green method for dissolution monitoring of pharmaceutical combinations. Meloxican and Pridinol. J Pharm Biomed Anal 2019;170:228-33. google scholar
31. Bebawy LI. Stability-indicating method for the determination of meloxicam and tetracaine hydrochloride in the presence of their degradation products. Spectrosc Lett 1998;31(4):797-820. google scholar
32. Redasanı VK, Patel CF, Chhajed CF, Surana SS. Quantitative Determination of Meloxicam in bulk and in tablet by UV Spectrophotometry. Int J Pharm Drug Anal 2014;2(3):246-50. google scholar
33. Pomykalski A, Hopkata H. Comparison of classic and derivative UV spectrophotometric methods for quantification of meloxicam and mefenamic acid in pharmaceutical preparations. Acta Pol Pharm 2011;68(3):317-23. google scholar
34. Kus S, Marczenko Z, Obarski N. Derivative UV-VIS spectrophotometry in analytical chemistry. Chem Anal 1996;41(6):889-927. google scholar
35. ICH, I. Q2 (R1): Validation of analytical procedures: text and methodology. In International conference on harmonization, Geneva, 2005. pp.1-13. google scholar