Comentários desativados em v11n4doi10.5935/sc.2019.014en

v11n4doi10.5935/sc.2019.014en

http://dx.doi.org/10.5935/sc.2019.014

Efficient UPLC and spectrophotometric MC methods for simultaneous determination of cefixime and sodium benzoate in their dosage form and in its degradation product of cefixime-E Isomer. Application of lean six sigma and in-vitro dissolution studies

Mohamed M. A.

Keywords: Cefixime; Sodium Benzoate; Lean Six Sigma; In vitro dissolution; MC; RP- UPLC.

Resumo: The main objective of this study is to develop and validate a novel RP-UPLC and spectrophotometric mean centering Methods for simultaneous estimation of cefixime and sodium benzoate in their dosage form and in Its Degradation Product of cefixime-E isomer and application of Quality tools and Lean Six Sigma methodologies to construe the data integrity of quality attributes which will give strength, confidence, and precision to control and emphasize that the Process Capability Index (Cpk) is >1.33. Isocratic chromatographic condition was evaluated at ambient temperature using Waters CORTECS® C18 column (50 mm × 4.6 mm, 2.7 µm particle size), with a mobile phase composing of acetonitrile: 0.05M Phosphate Buffer (35:65 v/v) at flow rate of 0.3 mL /minute and UV detection at 230 nm with injection volume of 0.5 µL and total run time of 7 min. The UV method is mean centering of the ratio spectra (MC), which is relied on mean centering of the first ratio spectral data of both drugs in their binary mixture at 225 nm for SDB, while CFX was detected at zero order spectra of 290 nm, as no overlapping from the combined drug has been found. The method was successfully applied to comparative in vitro dissolution studies for cefixime (CFX) in the Generic product; Rivaxime 200 mg Cap and Rivaxime 400 mg Cap therefore, it had been considered equivalent to the innovator product; Suprax 200 mg Cap and Suprax 400 mg Cap using FDA dissolution medium.

Referências Bibliográficas

  1. British Pharmacopoeia. Stationary Office Medicines and Healthcare Products Regulatory Agency; London.2020, 2.
  2. Description and Clinical Pharmacology for cefixime Drug U. S. Food and Drug Administration.2012, https://www.accessdata.fda.gov/drugsatfda.
  3. Description of sodium benzoate U. S. Food and Drug Administration.2017, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=184.1733.
  4. United States Pharmacopoeia Convention Inc, 2020, NF 38, Revision 42.
  5. Adam, E.H.; Saeed, A.E.; Barakat, I.E. Development and validation of a high-performance liquid chromatography method for determination of cefixime trihydrate and its degraded products formed under stress condition of UV light. Int. J. Pharm. Sci. Res.2012; 3:469-473.
  6. Aşçı, B.; Dinç Zor, Ş.; Aksu Dönmez, Ö. Development and validation of HPLC method for the simultaneous determination of five food additives and caffeine in soft drinks; Int. J. Anal. Chem.2016; 2016:1-8.
  7. Attimarad, M.V.; Alnajjar, A.O. A conventional HPLC-MS method for the simultaneous determination of ofloxacin and cefixime in plasma: Development and validation. J. Basic Clin. Pharm.2013; 4:36-41.
  8. Bhinge, S.D.; Malipatil, S.M. Development and validation of a stability-indicating method for the simultaneous estimation of cefixime and dicloxacillin using the RP-HPLC method. Journal of Taibah University for Science.2016; 10:734-744.
  9. Dhara, P.; Dhananjay, M.; Vandana, P.; Devanshi, P.; Hira, P. A Validated Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Cefixime Trihydrate and Levofloxacin Hemihydrate in Pharmaceutical Dosage Form. Int J Analytical Techn.2017; 3:1-12.
  10. Danafar, H.A. quick and easy high-performance liquid chromatography method for evaluation of cefixime in human plasma. Pharm. Biomed. Res.2015; 1:29-39.
  11. Elias, B.; Alfeen, A.; Determination of Cefuroxime Axetil and Cefixime Trihydrate in Pharmaceutical Dosage Forms by RP-HPLC Method. Pharm Anal Chem.2012, 2:114-118.
  12. Gören, A.C.; Bilsel, G.; Şimşek, A.; Bilsel, M.; Akçadağ, F.; Topal, K.; Ozgen, H. HPLC and LC–MS/MS methods for determination of sodium benzoate and potassium sorbate in food and beverages: Performances of local accredited laboratories via proficiency tests in Turkey. Food chemistry.2014; 175: 273-279.
  13. Hassouna, M.E.M.; Abdelrahman, M.M.; Mohamed, M.A. Validation of a Novel and Sensitive RP-HPLC Method for Simultaneous Determination of Cefixime Trihydrate and Sodium Benzoate in Powder for Oral Suspension Dosage Form. J Forensic Sci & Criminal Inves.2017; 2: 555600.
  14. Hussein, L.A.; Hussien, E.M.; Magdy, N.; Mohamed, H.S.; Simultaneous estimation of Ofloxacin and Cefixime in tablet form in presence of the inactive Ofloxacin USP Related compound A. Bulletin of Faculty of Pharmacy. Cairo University.2017; 55:171-176.
  15. Kundu, S.; Majumder, T.; Barat, P.K.; Ray, S.K. Development and validation of a HPLC-UV method for simultaneous determination of cefixime and ofloxacin in tablet formulation. Int. J. Pharm. Sci. Res.2015; 6:884-889.
  16. Patel, N.S.; Tandel, F.B.; Patel, Y.D.; Thakkar, K.B. Development and validation of stability indicating HPLC method for simultaneous estimation of cefixime and linezolid. Indian J. Pharm. Sci.2014; 76:535-540.
  17. Patwari, A.; Dabhi, M.; Rathod, I.; Desai, U.; Suhagia, B.; Sharma, M. Simultaneous Determination of ofloxacin and Cefixime in combined tablet Dosage Form by HPLC and Absorption correction method. Bull Pharm Res.2014, 4:112-117.
  18. Rao M.N., Veni P.R. and Haribabu B., Stability indicating RP-HPLC method for determination of cefixime and ornidazole in combined pharmaceutical dosage form. RJC.2015, 8: 477-486.
  19. Saikrishna, I.; Ganesh Akula, E.V.; Sreedevi, K.; Saikumar Bhupathi, S.R. Validation of Reversed – Phase Hplc Method for The Estimation of Cefixime In Cefixime Oral Suspension. IJPT.2010, 2: 385-395.
  20. Afkhami, A.; Felehgari, F.S.; Madrakian, T. Gold nanoparticles modified carbon paste electrode as an efficient electrochemical sensor for rapid and sensitive determination of cefixime in urine and pharmaceutical samples. Electrochimica Acta.2013, 103:125-133.
  21. Alnajjar, A.O. Simultaneous Determination of Ofloxacin and Cefixime in Tablet Formulation using Capillary Electrophoresis. J. Liq. Chromatogr. Relat. Technol.2013, 36: 2687-2697.
  22. Baboli, M.A.; Varnosfaderani, A.M. Rapid and simultaneous determination of tetracycline and cefixime antibiotics by mean of gold nanoparticles-screen printed gold electrode and chemometrics tools. Measurement.2014, 47: 145-149.
  23. Honda, S.; Taga, A.; Kakehi, K.; Koda, S.; Okamoto, Y. Determination of cefixime and its metabolises by high-performance capillary electrophoresis. Journal of Chromatography A.1992, 590:364-368.
  24. Deshpande, M.M.; Kasture, V.S.; Gosavi, S.A. Application of HPLC and HPTLC for the Simultaneous Determination of Cefixime Trihydrate and Ambroxol Hydrochloride in Pharmaceutical Dosage Form. Eurasian J. Anal. Chem.2010, 5: 227-238.
  25. Dhoka, M.V.; Gawande, V.T.; Joshi, P.P. Validated HPTLC Method for Determination of Cefixime Trihydrate and Erdosteine in Bulk and combined Pharmaceutical Dosage Form. Eurasian J Anal Chem.2013, 8:99-106.
  26. Popović, G.; Čakar, M.; Agbaba, D. Simultaneous determination of loratadine and preservatives in syrups by thin-layer chromatography. Acta Chromatogr.2007, 19:161-169.
  27. Rao, J.; Sethy, K.; Yadav, S. Validated HPTLC Method for Simultaneous Quantitation of Cefixime and Ofloxacin in Bulk Drug and in Pharmaceutical Formulation. Pharmacie Globale (IJCP).2011, 2:1-5.
  28. Anees, M.I.; Baig, M.S.; Tathe, A. Determination of cefixime and moxifloxacin in pharmaceutical dosage form by simultaneous equation and area under curve UV-spectrophotometric method. World J. Pharm. Pharm. Sci.2015, 4:1172-1179.
  29. Azmi, S.N.H.; Iqbal, B.; Al Mamari, J.K.; Al Hattali K.A.; Al Hadhrami, W.N. Method Development and Validation for the Determination of Cefixime in Pure and Commercial Dosage Forms by Specrophotometry. Int J Chem Molec Nucl Mat Metallurg Eng.2014, 8:595-601.
  30. Ethiraj, T.; Ramadoss, R.; Amudha, M. Sensitive spectroscopic method for content analysis of cefixime in solid dosage form using hydrotropy phenomenon. Chronicles of Young Scientists.2012, 3: 299- 303.
  31. Hassouna, M.E.M.; Abdelrahman, M.A.; Mohamed, M.A. Novel Spectro photometric Methods for Simultaneous Determination of Cefixime trihydrate and Sodium benzoate in Powder for Oral Suspension Dosage form. Glob J Oto.2017, 12:555-841.
  32. Kompany-Zareh, M.; Mirzaei, S. Spectrophotometric resolution of ternary mixtures of pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and sodium benzoate in syrups using wavelength selection by net analyte signals calculated with hybrid linear analysis. Analytica chimica acta.2004, 526:83-94.
  33. Kumar, A.; Kishore, L.; Nair, A.; Kaur, N. Kinetic spectrophotometric method for the estimation of cefixime in pharmaceutical formulations. Der Pharma Chemica.2011, 3: 279-291.
  34. Kumar, R.; Singh, P.; Singh, H. Development of colorimetric method for the analysis of pharmaceutical formulation containing both ofloxacin and cefixime. Int J Pharmacy and Pharm Sci.2011, 3:178-179.
  35. Pekamwar, S.S.; Kalyankar, T.M.; Tambe, B.V.; Wadher, S.J. Validated UV-Visible Spectrophotometric method for simultaneous estimation of cefixime and moxifloxacin in pharmaceutical dosage form. J Appl Pharm Sci.2015, 5:37-41.
  36. Ramadan, A.A.; Mandil, A.; Dahhan, M. UV-VIS Spectrophotometric study for determination of cefixime in pure form and in pharmaceuticals through complexation with Cu (II) using acetate-NaOH buffer in water: methanol. International J. of Pharmacy and Phar. Sci.2013, 5: 428-433.
  37. Shreya, R.S.; Prasanna, P.; Suddhasattya, D. Quantitative estimation of cefixime and moxifloxacin in pharmaceutical preparation by UV spectrophotometric method. Int J Pharm Tech Res.2013, 5:198-204.
  38. Somya, K.V.; Ravishankar, K.; Basha, D.P.; Kiranmayi, G.V. Estimation of caffeine and sodiun benzoate in caffeine and sodium benzoate injection by isoabsorption method (isobestic method). Int J Pharm Chem Biol Sci.2011,1: 26-3
  39. Sutar, S.V.; Sancheti, H.; Patil, S.S.; Spectrophotometric Method for Cefixime Trihydrate by Using Hydrotropic Agent. International Science Press, India.2013, 6:80-85.
  40. Hassouna, M.E.M.; Mohamed M.A. Comparative In-Vitro Dissolution Studies for Determination of Cefixime in an Innovator Product of Suprax Powder for Oral Suspension Dosage Form Using RP-HPLC Method; Glob J Oto.2018, 14:555886.
  41. Kamal, M.M.; Anisuzzaman, S.M.; Begum, A.A. Comparative dissolution studies of cefixime solid dosage forms available in Bangladesh market. J Biol Sci.2013, 2:115-120.
  42. Zhang, H.; Yu, L. Dissolution Testing for Solid Oral Drug Products: Theoretical Considerations. Am. Pharm. Rev.2004, 7: 26-31.
  43. Hassouna, M.E.M.; Mohamed, M.A. Modeling and optimization of a novel RP-UPLC and MCR spectrophotometric methods for simultaneous determination of five cephalosporins in spiked human plasma: Application to lean six sigma thinking hats and antimicrobial activity. Microchemical Journal.2019, 150: 104161.
  44. ICH guidelines. International Conference on Harmonization IFPMA, Geneva, Switzerland. 2005, Q2 (R1).