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Determination of Cefuroxime Axetil in Tablet by HPLC, UV and First-Order Derivative Spectroscopy Methods & Plasma by UV Spectroscopy Method

Year 2023, Volume: 10 Issue: 2, 541 - 548, 31.05.2023
https://doi.org/10.18596/jotcsa.1222357

Abstract

It was aimed to develop and validate the UV spectroscopic, the first-order derivative spectroscopy, and the HPLC method for determination of cefuroxime axetil in bulk and tablets and also in spiked human plasma samples by UV spectroscopy method. In the spectroscopic analyses, the maximum absorbance of cefuroxime axetil in acetonitrile was obtained at 277 nm wavelength in the spectra. In first-order derivative spectroscopy method, two peaks were observed in spectra, a maximum at 258 nm and a minimum at 298 nm. 298 nm wavelength was used in the study. In HPLC-UV study, parameters were chosen as follows: C18 column, 0.1% acetic acid-acetonitrile (30:70; v/v) for mobile phase, 1.0 mL/min of flow rate, 280 nm of wavelength, 10 μL of injection volume and etodolac (2.5 μg/mL) as internal standard. Accuracy, precision, recovery, linearity and sensitivity parameters were determined for each of the three methods. Developed and validated methods were successfully applied on 4 tablets which are named as Cefaks, Cefurol, Aksef ve Enfexia. As a result, it is claimed that proposed method is sensitive, precise, accurate, and successfully used in quality control studies in the drug industry.

References

  • 1. Powell DA, James NC, Ossi MJ, Nahata MC, Donn KH. Pharmacokinetics of cefuroxime axetil suspension in infants and children. Antimicrob Agents Chemother [Internet]. 1991 [cited 2023 May 30];35(10):2042–5.
  • 2. Öner M. Genel Mikrobiyoloji. Ege Üniversitesi Fen Fakültesi Kitaplar Serisi. 2001; 992:231-245.
  • 3. Bush K, Jacoby GA, Medeiros AA. A functional classification scheme for beta-lactamases and its correlation with molecular structure. Antimicrob Agents Chemother [Internet]. 1995 [cited 2023 May 30];39(6):1211–33.
  • 4. Scott LJ, Ormrod D, Goa KL. Cefuroxime axetil: an updated review of its use in the management of bacterial infections. Drugs [Internet]. 2001 [cited 2023 May 30];61(10):1455–500.
  • 5. Martindale W, Reynolds JEF. The Extra Pharmacopoeia. Pharmaceutical Press, 1 Lambeth Street, London, SEI 7JN, UK, 1999; 177.
  • 6. Harding SM, Williams PEO, Ayrton J. Pharmacology of Cefuroxime as the 1-acetoxyethyl ester in volunteers. Antimicrob Agents Chemother [Internet]. 1984 [cited 2023 May 30];25(1):78–82.
  • 7. Akalın HE. Antibiyotiklere Direnç Gelişmesi ve Antibiyotik Kullanımı. Klinik uygulamalarda antibiyotikler ve diğer antimikrobiyal ilaçlar. Baskı. Ankara, Güneş Kitabevi Ltd. Şti., 1994; 38–39.
  • 8. Al-Said MS, Al-Khamis KI, Niazy EM, El-Sayed YM, Al-Rashood KA, Al-Bella S, et al. Bioequivalence evaluation of two brands of cefuroxime 500 mg tablets (Cefuzime and Zinnat) in healthy human volunteers. Biopharm Drug Dispos [Internet]. 2000 [cited 2023 May 30];21(6):205–10.
  • 9. Murillo JA, Lemus JM, García LF. Spectrofluorimetric analysis of cefuroxime in pharmaceutical dosage forms. J Pharm Biomed Anal [Internet]. 1994 [cited 2023 May 30];12(7):875–81.
  • 10. Elias B, Alfeen MA. Determination of Cefuroxime Axetil and Cefixime Trihydrate in Pharmaceutical Dosage Forms by RP-HPLC Method. Pharmaceutical Analytical Chemistry: Open Access [Internet]. 2016 [cited 2023 May 30];2(2):0–0.
  • 11. (PDF) A Validated High performance liquid chromatography (HPLC) Method for the Estimation of Cefuroxime axetil [Internet]. [cited 2023 May 30].
  • 12. Alfeen M. New Development Method for Determination of Cefuroxime Axetil (CUA) and Cefprozil (CZ) in Pharmaceutical Drugs by RP-HPLC. Am J Biomed Sci Res. 2019 Jul 17;4(1):54–7.
  • 13. Patel N, Mehta I, Patel DrC, Patel DrMM. Development And Validation Of Rp-Hplc Method For Combination Of Ce-furoxime Axetil And Linezolid In Pharmaceutical Dosage form. International Journal of Pharmaceutics and Drug Analysis [Internet]. 2017 Dec 4 [cited 2023 May 30];5:429–41.
  • 14. Krzek J, Da ˛ Browska-Tylka / M. Simultaneous Determination of Cefuroxime Axetil and Cefuroxime in Pharmaceutical Preparations by Thin-Layer Chromatography and Densitometry. Chromatographia 2003 58:3 [Internet]. 2003 Aug [cited 2023 May 30];58(3):231–4.
  • 15. Pajchel G, Tyski S. Adaptation of capillary electrophoresis to the determination of selected cephalosporins for injection. J Chromatogr A [Internet]. 2000 Oct 20 [cited 2023 May 30];895(1–2):27–31.
  • 16. Shinde M, Pishawikar S, More H. Spectrophotometeric Determination of Cefuroxime Axetil from bulk and in its tablet dosage form. Indian J Pharm Sci [Internet]. 2008 Feb 1 [cited 2023 May 30];70(2):249.
  • 17. Ramadan AA, Bakdash M. Direct Spectrophotometric Determination of Cefuroxime Axetil in Pure Form and Pharmaceutical Dosage Forms. JOURNAL OF ADVANCES IN CHEMISTRY [Internet]. 2018 Dec 1 [cited 2023 May 30];15(2):6282–95.
  • 18. Pritam J, Manish P, Sanjay S. Development and validation of UV-Spectrophotometric method for determination of Cefuroxime Axetil in bulk and in Formulation “Development and validation of UV-Spectrophotometric method for determination of Cefuroxime Axetil in bulk and in Formulation.” Int J Drug Dev & Res [Internet]. [cited 2023 May 30];3(4):318–22.
  • 19. Validated spectrophotometric methods for the determination of Cefuroxime Axetil in bulk drug and tablets | Request PDF [Internet]. [cited 2023 May 30].
  • 20. International Conference On Harmonisatıon Of Technical Requirements For Registration Of Pharmaceuticals For Human Use Ich Harmonised Tripartite Guıdeline Validatıon Of Analytical Procedures: Text And Methodology Q2(R1).
  • 21. Hladová M, Martinka J, Rantuch P, Nečas A. Review of Spectrophotometric Methods for Determination of Formaldehyde. Research Papers Faculty of Materials Science and Technology Slovak University of Technology. 2019 Jun 1;27(44):105–20.
  • 22. Hamilton RJ, Sewell PA. Introduction to high performance liquid chromatography. 1st ed. Chapman and Hall New York, 1982.
Year 2023, Volume: 10 Issue: 2, 541 - 548, 31.05.2023
https://doi.org/10.18596/jotcsa.1222357

Abstract

Supporting Institution

Atatürk Üniversitesi

References

  • 1. Powell DA, James NC, Ossi MJ, Nahata MC, Donn KH. Pharmacokinetics of cefuroxime axetil suspension in infants and children. Antimicrob Agents Chemother [Internet]. 1991 [cited 2023 May 30];35(10):2042–5.
  • 2. Öner M. Genel Mikrobiyoloji. Ege Üniversitesi Fen Fakültesi Kitaplar Serisi. 2001; 992:231-245.
  • 3. Bush K, Jacoby GA, Medeiros AA. A functional classification scheme for beta-lactamases and its correlation with molecular structure. Antimicrob Agents Chemother [Internet]. 1995 [cited 2023 May 30];39(6):1211–33.
  • 4. Scott LJ, Ormrod D, Goa KL. Cefuroxime axetil: an updated review of its use in the management of bacterial infections. Drugs [Internet]. 2001 [cited 2023 May 30];61(10):1455–500.
  • 5. Martindale W, Reynolds JEF. The Extra Pharmacopoeia. Pharmaceutical Press, 1 Lambeth Street, London, SEI 7JN, UK, 1999; 177.
  • 6. Harding SM, Williams PEO, Ayrton J. Pharmacology of Cefuroxime as the 1-acetoxyethyl ester in volunteers. Antimicrob Agents Chemother [Internet]. 1984 [cited 2023 May 30];25(1):78–82.
  • 7. Akalın HE. Antibiyotiklere Direnç Gelişmesi ve Antibiyotik Kullanımı. Klinik uygulamalarda antibiyotikler ve diğer antimikrobiyal ilaçlar. Baskı. Ankara, Güneş Kitabevi Ltd. Şti., 1994; 38–39.
  • 8. Al-Said MS, Al-Khamis KI, Niazy EM, El-Sayed YM, Al-Rashood KA, Al-Bella S, et al. Bioequivalence evaluation of two brands of cefuroxime 500 mg tablets (Cefuzime and Zinnat) in healthy human volunteers. Biopharm Drug Dispos [Internet]. 2000 [cited 2023 May 30];21(6):205–10.
  • 9. Murillo JA, Lemus JM, García LF. Spectrofluorimetric analysis of cefuroxime in pharmaceutical dosage forms. J Pharm Biomed Anal [Internet]. 1994 [cited 2023 May 30];12(7):875–81.
  • 10. Elias B, Alfeen MA. Determination of Cefuroxime Axetil and Cefixime Trihydrate in Pharmaceutical Dosage Forms by RP-HPLC Method. Pharmaceutical Analytical Chemistry: Open Access [Internet]. 2016 [cited 2023 May 30];2(2):0–0.
  • 11. (PDF) A Validated High performance liquid chromatography (HPLC) Method for the Estimation of Cefuroxime axetil [Internet]. [cited 2023 May 30].
  • 12. Alfeen M. New Development Method for Determination of Cefuroxime Axetil (CUA) and Cefprozil (CZ) in Pharmaceutical Drugs by RP-HPLC. Am J Biomed Sci Res. 2019 Jul 17;4(1):54–7.
  • 13. Patel N, Mehta I, Patel DrC, Patel DrMM. Development And Validation Of Rp-Hplc Method For Combination Of Ce-furoxime Axetil And Linezolid In Pharmaceutical Dosage form. International Journal of Pharmaceutics and Drug Analysis [Internet]. 2017 Dec 4 [cited 2023 May 30];5:429–41.
  • 14. Krzek J, Da ˛ Browska-Tylka / M. Simultaneous Determination of Cefuroxime Axetil and Cefuroxime in Pharmaceutical Preparations by Thin-Layer Chromatography and Densitometry. Chromatographia 2003 58:3 [Internet]. 2003 Aug [cited 2023 May 30];58(3):231–4.
  • 15. Pajchel G, Tyski S. Adaptation of capillary electrophoresis to the determination of selected cephalosporins for injection. J Chromatogr A [Internet]. 2000 Oct 20 [cited 2023 May 30];895(1–2):27–31.
  • 16. Shinde M, Pishawikar S, More H. Spectrophotometeric Determination of Cefuroxime Axetil from bulk and in its tablet dosage form. Indian J Pharm Sci [Internet]. 2008 Feb 1 [cited 2023 May 30];70(2):249.
  • 17. Ramadan AA, Bakdash M. Direct Spectrophotometric Determination of Cefuroxime Axetil in Pure Form and Pharmaceutical Dosage Forms. JOURNAL OF ADVANCES IN CHEMISTRY [Internet]. 2018 Dec 1 [cited 2023 May 30];15(2):6282–95.
  • 18. Pritam J, Manish P, Sanjay S. Development and validation of UV-Spectrophotometric method for determination of Cefuroxime Axetil in bulk and in Formulation “Development and validation of UV-Spectrophotometric method for determination of Cefuroxime Axetil in bulk and in Formulation.” Int J Drug Dev & Res [Internet]. [cited 2023 May 30];3(4):318–22.
  • 19. Validated spectrophotometric methods for the determination of Cefuroxime Axetil in bulk drug and tablets | Request PDF [Internet]. [cited 2023 May 30].
  • 20. International Conference On Harmonisatıon Of Technical Requirements For Registration Of Pharmaceuticals For Human Use Ich Harmonised Tripartite Guıdeline Validatıon Of Analytical Procedures: Text And Methodology Q2(R1).
  • 21. Hladová M, Martinka J, Rantuch P, Nečas A. Review of Spectrophotometric Methods for Determination of Formaldehyde. Research Papers Faculty of Materials Science and Technology Slovak University of Technology. 2019 Jun 1;27(44):105–20.
  • 22. Hamilton RJ, Sewell PA. Introduction to high performance liquid chromatography. 1st ed. Chapman and Hall New York, 1982.
There are 22 citations in total.

Details

Primary Language English
Subjects Analytical Chemistry
Journal Section RESEARCH ARTICLES
Authors

Atakan Turan 0000-0002-0745-0296

Yücel Kadıoğlu 0000-0001-6590-7306

Publication Date May 31, 2023
Submission Date December 21, 2022
Acceptance Date April 28, 2023
Published in Issue Year 2023 Volume: 10 Issue: 2

Cite

Vancouver Turan A, Kadıoğlu Y. Determination of Cefuroxime Axetil in Tablet by HPLC, UV and First-Order Derivative Spectroscopy Methods & Plasma by UV Spectroscopy Method. JOTCSA. 2023;10(2):541-8.