Research Article
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Development and Validation of HPLC-UV Method for Determination of Meloxicam in Tablet Dosage Formulation

Year 2023, Volume: 3 Issue: 3, 59 - 63, 31.07.2023
https://doi.org/10.5152/Pharmata.2023.23008

Abstract

Objective: The development and validation of a novel, simple, and quick high-performance liquid chromatography– ultra viole t detection (HPLC-UV) technique for measuring meloxicam in pharmaceutical formulations was made.

Methods: The technique parameters were tuned to be 0.8 mL/min flow rate, variable column temperature, 290 nm wavelength, 10 μL injection volume, and a mobile phase combination of water (with 0.6% triflour acetic acid—pH:2.6) and methanol (30 : 70 v/v) to carry out this study. In this study, valsartan was used as ınternal standard (IS).

Results: Specificity, the limit of quantitation (LOQ), linearity, accuracy, precision, stability, recovery, and ruggedness were all tested. The technique was linear between 1.0 μg/mL and 50 μg/mL, with precision (relative standard d (RSD) %) and accuracy (relative error %) of less than 3.9% and 0.7%, respectively. The LOQ and LOD values of method were 1.00 and 0.25 μg/mL, respectively. Analytical recovery from pharmaceutical preparations was performed according to the standard addition method, and the average analytical recovery value was determined as 100.4%. The developed and validated HPLC-UV method was successfully applied to 4 commercial tablet dosage formulations obtained from a local pharmacy store in Turkey (Zeloxim, Melox, Meksun, Exen).

Conclusion: It has been concluded that the developed HPLC-UV method is sensitive, accurate, and precise and can be successfully applied in quality control studies in the pharmaceutical industry.

Ethical Statement

Since this study is an in vitro (quantification in pharmaceutical preparations) study, ethics committee approval is not required.

References

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  • 2. Del Tacca M, Colucci R, Fornai M, Blandizzi C. Efficacy and tolerability of meloxicam, a COX-2 preferential nonsteroidal anti-inflammatory drug – a review. Clin Drug Investig. 2002;22(12):799-818. [CrossRef]
  • 3. Cahoon EK, Rajaraman P, Alexander BH, Doody MM, Linet MS, Freedman DM. Use of nonsteroidal anti-inflammatory drugs and risk of basal cell carcinoma in the United States radiologic technologists study. Int J Cancer. 2012;130(12):2939-2948. [CrossRef]
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  • 6. Argoff CE. Recent developments in the treatment of osteoarthritis with NSAIDs. Curr Med Res Opin. 2011;27(7):1315-1327. [CrossRef]
  • 7. Awasthi SS, Kumar TG, Manisha P, Preeti Y, Kumar SS. Development of Meloxıcam formulatıons utılızıng ternary complexatıon for solubılıty enhancement. Pak J Pharm Sci. 2011;24(4):533-538.
  • 8. Nikolaychuk PA. UV-spectrophotometric determination of the active pharmaceutical ingredients meloxicam and nimesulide in cleaning validation samples with sodium carbonate. Multidiscip Sci J. 2023;6(2):248-266. [CrossRef]
  • 9. Mahood AM, Najm NH. Spectrophotometric Estamation of meloxicam using charge transfer complex. IOP Conf Ser Mater Sci Eng. 2019;571(1). [CrossRef]
  • 10. 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. 2015;6(7):1040-1045.
  • 11. 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 Tech. 2013;20:111-115.
  • 12. Tomuta I, Iovanov R, Bodoki E, Leucuta SE. Quantification on intact tablets by near infrared spectrometry and Chemometry. Farmacia. 2010;58(5):559-571.
  • 13. Nemutlu E, Kir S. Method development and validation for the analysis of meloxicam in tablets by CZE. J Pharm Biomed Anal. 2003;31(2):393-400. [CrossRef].
  • 14. Sahoo NK, Sahu M, Rao PS, Rani NS, Devi JI, Ghosh G. Validation of assay indicating method development of meloxicam in bulk and some of its tablet dosage forms by RP-HPLC. Springerplus. 2014;3:95. [CrossRef]
  • 15. Arayne MS, Sultana N, Siddiqui FA. A new RP-HPLC method for analysis of meloxicam in tablets. Pak J Pharm Sci. 2005;18(1):58-62.
  • 16. Nemutlu E, Sayın F, Başcı NE, Kır S. A validated HPLC method for the determination of meloxicam in pharmaceutical preparations. Hacettepe Univ J Fac Pharm. 2007;27:107-118.
  • 17. 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):219-225. [CrossRef]
  • 18. 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):257-264. [CrossRef]
  • 19. Mahmood KT, Khan B, Ashraf M, Haq IU. Specific and simple HPLC assay of ecofriendly meloxicam in pharmaceutical formulations. J Pharm Sci Res. 2010;2(12):878-883.
  • 20. Ahmad R, Hailat M, Zakaraya Z, Al Meanazel O, Abu Dayyih W. Development and validation of an HPLC method for the determination of meloxicam and pantoprazole in a combined formulation. Analytica. 2022;3(2):161-177. [CrossRef]
  • 21. Parys W, Bober K, Pyka-Pająk A, Dołowy M. The application of TLC and densitometry for quantitative determination of meloxicam in tablets. Curr Pharm Anal. 2019;15(7):785-794. [CrossRef]
  • 22. Desai N, Amin P. Stability indicating HPTLC determination of meloxicam. Indian J Pharm Sci. 2008;70(5):644-647. [CrossRef].
  • 23. ICH. Q2B guideline validation of analytical procedures: methodology. International Conference on Harmonization of Technical Requirements for the Registration of Drugs for Human Use. Geneva, Switzerland; 1997.
  • 24. ICH Harmonised Tripartite Guideline. Validation of analytical procedures: text and methodology Q2(R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Geneva; 2005:1-13.
  • 25. Joseph-Charles J, Bertucat M. Determination of meloxicam in tablet formulations by ultraviolet spectrophotometry and high-performance liquid chromatography. Ana. Lett. 1999; 32(10): 2051-2059.
Year 2023, Volume: 3 Issue: 3, 59 - 63, 31.07.2023
https://doi.org/10.5152/Pharmata.2023.23008

Abstract

References

  • 1. Nageswara Rao R, Meena S, Raghuram Rao A. 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):349-363. [CrossRef]
  • 2. Del Tacca M, Colucci R, Fornai M, Blandizzi C. Efficacy and tolerability of meloxicam, a COX-2 preferential nonsteroidal anti-inflammatory drug – a review. Clin Drug Investig. 2002;22(12):799-818. [CrossRef]
  • 3. Cahoon EK, Rajaraman P, Alexander BH, Doody MM, Linet MS, Freedman DM. Use of nonsteroidal anti-inflammatory drugs and risk of basal cell carcinoma in the United States radiologic technologists study. Int J Cancer. 2012;130(12):2939-2948. [CrossRef]
  • 4. Meloxicam properties. Available at: https ://ww w.wor ldofc hemic als.c om/ch emica ls/ch emica l-pro perti es/me loxic am.ht ml.
  • 6. Argoff CE. Recent developments in the treatment of osteoarthritis with NSAIDs. Curr Med Res Opin. 2011;27(7):1315-1327. [CrossRef]
  • 7. Awasthi SS, Kumar TG, Manisha P, Preeti Y, Kumar SS. Development of Meloxıcam formulatıons utılızıng ternary complexatıon for solubılıty enhancement. Pak J Pharm Sci. 2011;24(4):533-538.
  • 8. Nikolaychuk PA. UV-spectrophotometric determination of the active pharmaceutical ingredients meloxicam and nimesulide in cleaning validation samples with sodium carbonate. Multidiscip Sci J. 2023;6(2):248-266. [CrossRef]
  • 9. Mahood AM, Najm NH. Spectrophotometric Estamation of meloxicam using charge transfer complex. IOP Conf Ser Mater Sci Eng. 2019;571(1). [CrossRef]
  • 10. 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. 2015;6(7):1040-1045.
  • 11. 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 Tech. 2013;20:111-115.
  • 12. Tomuta I, Iovanov R, Bodoki E, Leucuta SE. Quantification on intact tablets by near infrared spectrometry and Chemometry. Farmacia. 2010;58(5):559-571.
  • 13. Nemutlu E, Kir S. Method development and validation for the analysis of meloxicam in tablets by CZE. J Pharm Biomed Anal. 2003;31(2):393-400. [CrossRef].
  • 14. Sahoo NK, Sahu M, Rao PS, Rani NS, Devi JI, Ghosh G. Validation of assay indicating method development of meloxicam in bulk and some of its tablet dosage forms by RP-HPLC. Springerplus. 2014;3:95. [CrossRef]
  • 15. Arayne MS, Sultana N, Siddiqui FA. A new RP-HPLC method for analysis of meloxicam in tablets. Pak J Pharm Sci. 2005;18(1):58-62.
  • 16. Nemutlu E, Sayın F, Başcı NE, Kır S. A validated HPLC method for the determination of meloxicam in pharmaceutical preparations. Hacettepe Univ J Fac Pharm. 2007;27:107-118.
  • 17. 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):219-225. [CrossRef]
  • 18. 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):257-264. [CrossRef]
  • 19. Mahmood KT, Khan B, Ashraf M, Haq IU. Specific and simple HPLC assay of ecofriendly meloxicam in pharmaceutical formulations. J Pharm Sci Res. 2010;2(12):878-883.
  • 20. Ahmad R, Hailat M, Zakaraya Z, Al Meanazel O, Abu Dayyih W. Development and validation of an HPLC method for the determination of meloxicam and pantoprazole in a combined formulation. Analytica. 2022;3(2):161-177. [CrossRef]
  • 21. Parys W, Bober K, Pyka-Pająk A, Dołowy M. The application of TLC and densitometry for quantitative determination of meloxicam in tablets. Curr Pharm Anal. 2019;15(7):785-794. [CrossRef]
  • 22. Desai N, Amin P. Stability indicating HPTLC determination of meloxicam. Indian J Pharm Sci. 2008;70(5):644-647. [CrossRef].
  • 23. ICH. Q2B guideline validation of analytical procedures: methodology. International Conference on Harmonization of Technical Requirements for the Registration of Drugs for Human Use. Geneva, Switzerland; 1997.
  • 24. ICH Harmonised Tripartite Guideline. Validation of analytical procedures: text and methodology Q2(R1). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Geneva; 2005:1-13.
  • 25. Joseph-Charles J, Bertucat M. Determination of meloxicam in tablet formulations by ultraviolet spectrophotometry and high-performance liquid chromatography. Ana. Lett. 1999; 32(10): 2051-2059.
There are 24 citations in total.

Details

Primary Language English
Subjects Pharmacology and Pharmaceutical Sciences (Other)
Journal Section Research Articles
Authors

Reyhan Sıla Çelik This is me 0009-0004-1322-465X

Burak Bayrak 0000-0001-6550-6916

Yücel Kadıoğlu 0000-0001-6590-7306

Publication Date July 31, 2023
Published in Issue Year 2023 Volume: 3 Issue: 3

Cite

EndNote Çelik RS, Bayrak B, Kadıoğlu Y (July 1, 2023) Development and Validation of HPLC-UV Method for Determination of Meloxicam in Tablet Dosage Formulation. Pharmata 3 3 59–63.

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