• Online ISSN : 2313-1519
  • Print    ISSN : 1812-2892
Abstract - Validated stability Spectrophotometric process for estimation vancomycin antibiotic degradation behavior in pharmaceutical kinds
< Back
[PDF]
Mohauman Mohaummed Majeed Al-Rufaie

ABSTRACT

Objective: To estimate the dissolution behavior of the antibiotic vancomycin hydrochloride in pharmaceutical formulations, a novel, quick as well as innovative stabilization implying spectrophotometric process has been created and certified. Using the spectrophotometric process to calculate the constant acid dissociation (Ka).

Material and methods: The process focused on the observed drug oxidation by a documented excess of Ceric ammonium nitrate in hydrochloride acid solution as well as corresponding identification of unreacted oxidant by combining it with methylene blue respectively. The oxidant reacted correlates to the substance of the compound. As well as wave length absorbance calculation 588 nm. This approach follows Beer-Lambert plot regression showed remarkable concentration range 1-50 ppm associations. It was a coefficient of correlation of 0.9982. Calculated the limits of molar absorptivity 6.9117× 104 (L . mol-1. cm-1) , sandal sensitivity 0.02 µg. cm-2, identification 0.410 ppm, as well as quantification 0.731 ppm. The method's precision and accuracy was established and checked.

Results: The stoichiometric proportions were analyzed for the aforementioned product. This measured the growing conditions of reaction as well as other analytical variables. The technique has decent repeatability with little than two percent relative standard deviation (RSD percentage).

Conclusion: The impact of the material typically often used in such  medications as excipients was examined. The suggested technique have been implemented in pharmaceutical products to assess such drugs. The findings showed that the technique is as reliable and repeatable as the approved technique.

Keywords: validated stability, spectrophotometric, vancomycin, antibiotic, pharmaceutical forms

Corresponding author: Mohauman Mohammed Majeed AL-Rufaie, Chemistry Department, Faculty of Science, Kufa University, Najaf, Iraq. Tel: 07809086646, Fax: 07809086646.

E-mail: muhaimin.alrufaie@uokufa.edu.iq

 

References

1. Willian, D.H., Kalman, J.R. Structural and mode of action studies on the antibiotic vancomycin. Evidence from 270-MHz proton magnetic resonance. J. Am. Chem. Soc. 1977; 99:2768.
https://doi.org/10.1021/ja00450a058

2. The British Pharmacopoeia, Her Majesty's Stationary Office. 2009. London, p.6297,6298,6301,10241,10246,10247.

3. Tavares W. Manual de antibióticos e quimioterápicos. Atheneu: São Paulo. 2002; 3:151.

4. Marta M.D.C., Robson M.O., Marcos M.G. Analytical Methods for Vancomycin hydrochloride determination in biological Fluids and in pharmaceuticals. Quim. Nova. 2007; 30(2):395.
https://doi.org/10.1590/S0100-40422007000200029

5. Takashi A., Noriyuki N., Toshio K. Investigation of enation selective separation of quinolone carboxylic acids by capillary zone electrophoresis using vancomycin as a chiral selector. Journal of Chromatography A. 1996; 736(1-2):303. https://doi.org/10.1016/0021-9673(95)01368-7

6. Musenga A., Mandrioli R., Zecchi V., Luppi B., Fanali S., Raggi M.A. Capillary electrophoretic analysis of the antibiotic vancomycin in innovative micro particles and in commercial formulations. J. of pharmaceutical and biomedical analysis. 2006; 42-32. https://doi.org/10.1016/j.jpba.2005.11.022

7. Francois J., Corinne G., Robert C.T., Henri M. Determination of Vancomycin in Human Serum by High-Pressure Liquid Chromatography Antimicrobial Agents Chromatography. 1985. 27(4):503. https://doi.org/10.1128/AAC.27.4.503

8. Forlay-FRICK, Nagy Z.B., Fakete A., Kettrup A., Gebefugi I. Reverse Phase HPLC method for Determination of Vancomycin in influenza Vaccine. J. of Liquid Chromatography & Related Technologies. 2001; 24(2):497. https://doi.org/10.1081/JLC-100103388

9. María J.D., Francisco G., LópezA., Sánchez N. Development and validation of an HPLC method for vancomycin and its application to a pharmacokinetic study. Journal of Pharmaceutical and Biomedical Analysis. 2008; 48(3,4):835. https://doi.org/10.1016/j.jpba.2008.05.040

10. Nirmala K., Ramesh R.R. Determination of vancomycin by using RP-HPLC method in pharmaceutical preparations. Inter. Journal of Res. in Ayurveda and Pharmacy (IJRAP). 2013; 4(1):117. https://doi.org/10.7897/2277-4343.04139

11. Krishna M., Andrew S. P., Guru B., Jeffrey W. Development and Validation of a Rapid High-Performance Liquid Chromatography Method with UV Detection for the Determination of Vancomycin in Mouse Plasma. Chromatography Separation Techniques. 2013; 1(4):1.

12. Abu-Shandi K.H. Determination of vancomycin in human plasma using high-performance liquid chromatography with fluorescence detection. Anal Bio anal. Chem. 2009; 395-527. https://doi.org/10.1007/s00216-009-2948-9

13. Farin D, Piva G.A., Gozlan I, Kitzes-Cohen R.:A modified HPLC method for the determination of vancomycin in plasma and tissues and comparison to FPIA (TDX). J Pharm Biomed Anal. 1998; 18:367. https://doi.org/10.1016/S0731-7085(98)00095-8

14. Lopez K.J., Bertoluci D.F., Vicente K.M., Dell'Aquilla A.M., Santos S.R. Simultaneous determination of cefepime, vancomycin and impanel in human plasma of burn patients by high-performance liquid chromatography. J Chromatogr B Analyt Technol Biomed Life Sci. 2007; 860:241.
https://doi.org/10.1016/j.jchromb.2007.10.041

15. Jesus Valle M.J., Lopez F.G., Navarro A.S. Development and validation of an HPLC method for vancomycin and its application to a pharmacokinetic study. J Pharm Biomed Anal. 2008; 48:835.
https://doi.org/10.1016/j.jpba.2008.05.040

16. Ghassempour A, Darbandi M.K., Asghari F.S. Comparison of pyrolysis-mass spectrometry with high performance liquid chromatography for the analysis of vancomycin in serum. Talanta. 2001; 55:573. https://doi.org/10.1016/S0039-9140(01)00460-X

17. Zhang T, Watson D.G., Azike C, Tettey J.N., Stearns A.T. Determination of vancomycin in serum by liquid chromatography-high resolution full scan mass spectrometry. J Chromatogr B Analyst Technol Biomed Life Sci. 2007; 857:352. https://doi.org/10.1016/j.jchromb.2007.07.041

18. Favetta P., Guitto J., Bleyzac N., Dufresne C., Bureau J. New sensitive assay of vancomycin in human plasma using high-performance liquid chromatography and electrochemical detection. J  Chromatogr B Biomed Sci Appl. 2001; 751:377. https://doi.org/10.1016/S0378-4347(00)00484-9

19. Ackerman B.H., Berg H.G., Strate R.G., Rostschafer J.C. Comparison of radioimmunoassay and fluorescent polarization immunoassay for quantitative determination of vancomycin concentrations in serum. Journal of Clinical Microbiology. 1985; 18(4):994. https://doi.org/10.1128/JCM.18.4.994-995.1983

20. Khataee A.R., Hasanzadeh A., Iranifam M., Fathinia M., Hanifehpour Y., Joo S.W. CuO nano sheets-enhanced flow-injection chemiluminescence system for determination of vancomycin in water, pharmaceutical and human serum. Spectrochimica Acta Part A. Molecular Bimolecular Spectroscopy, 2014; 122:737. https://doi.org/10.1016/j.saa.2013.12.014

21. Hermida J., Zaera S., Tutor J.C. Therapeutic drug monitoring in the COBAS integra 400 analyzer. Therapeutic Drug Monitoring. 2001; 23(6):725. https://doi.org/10.1097/00007691-200112000-00022

22. Belal F., El-Ashry S.M., El-kerdawy M.M., El-Wasseef D.E. Voltammetric determination of vancomycin in dosage forms through treatment with nitrous acid. Arzneimittelforschung, 2001; 51(9):763. https://doi.org/10.1055/s-0031-1300112

23. Fooks J. R., McGilveray I. J., Strickland, R.D. Colorimetric assay and improved method for identification of vancomycin hydrochloride. Journal of Pharmaceutical Sciences. 1968; 57(2):314.
https://doi.org/10.1002/jps.2600570216

24. El-Ashry S.M., Belal F., El-Kerdawy M.M., Elwasseef D.R. Spectrophotometric determination of some phenolic antibiotics in dosage forms. Mikrochim Acta. 2000; 135:191. https://doi.org/10.1007/s006040070010

25. Sastry C.S.P., Rao T.S., Rao P.S.N.H., Prassa U.V. Assay of vancomycin and dobutamine using sodium metaperiodate. Mikrochim Acta. 2002; 140:109. https://doi.org/10.1007/s00604-002-0900-1

26. Al-Abachi M.Q., Fadi J. Y. Normal and reverse flow injection- spectrophotometric determination of Vancomycin Hydrochloride in Pharmaceutical Preparations Using 2, 4-Dinitrophenylhydrazine. Iraqi Journal of Science. 2014; 55(2B):623.

27. Sadeem S.A., Omar T.H. Spectrophotometric Determination of Vancomycin Hydrochloride (Batch and Flow-Injection) Using O-Nitro aniline as diazotized Chromogenic Reagent. Iraqi Journal of Science. 2015; 56(4B):3025 .

28. Al-Rufaie M.M., Al-Sharefy A.N., Kathem K.H. Spectrophotometric Determination of Doxycycline Hyclate in Pharmaceutical Preparations Using Oxidative coupling reaction. J. of Applicable Chemistry. 2013; 2(4):931.

29. Al-Rufaie M.M. New spectrophotometric method for the determination of Sulfamethoxazole drug. W. J. of pharmacy and pharmaceutical sciences. 2016; 5(3):172.

30. Al-Rufaie M.M., Al-Sharefy A.N., Kathem K.H. New spectrophotometric method for the determination chlorpromazine hydrochloride in pharmaceutical preparations by using oxidative coupling reaction. Inter. J. of Uni. Pharmacy and Bio Sciences. 2013; 2(4):19.

31. Hanaa K..A.T., Al-Rufaie M. M., Zahraa Y.M. Spectrophotometric determination of metoclopramide medicine in bulk form and in pharmaceuticals using orcinol as reagent. Ovidius University Annals of Chemistry. 2018; 29(2):85. https://doi.org/10.2478/auoc-2018-0012

32. Al-Rufaie M.M. Modern kinetic spectrophotometric procedure for estimation of furosemide drug as bulk form and in pharmaceuticals preparations. Curr. Issues Pharm. Med. Sci. 2016; 29(4):184.
https://doi.org/10.1515/cipms-2016-0039

33. Hind H. Spectrophotometric Determination of Vancomycin Hydrochloride in Pharmaceutical Preparations through Diazotization and Coupling Reactions. Iraqi Journal of Science. 2014; 55(4B):1684.

34. Nabeel S.O., AL-Saffar R.S. Spectrophotometric Determination of Amoxicillin in Pharmaceutical Preparations. Inter. J. of Enhanced Res. in Sci. Tech. & Eng. 2015; 4(6):167.

35. Pande S., Parikh J. Development and Validation of UV- Spectrophotometric Method for estimation of Vancomycin Hydrochloride. J. of drug delivery and therapeutics. 2019; 9(3):116.

36. de-Levie R. Principles of Quantitative Chemical Analysis. The McGraw-Hill Companies, Inc., Singapore. 1997; 132.

37. Abdul Satar R.S. Ph. D. Thesis. Baghdad University. 2006; 115.

38. Al-Rufaie M.M., Al-labban H.M.Y., Salih N.S. Reduction and assessment of chloramphenicol antibiotic as pure from and in various kinds of pharmaceuticals by utilizing spectrophotometric approach. Iran. J. of Org.Chem. 2017; 9(2):2087.

39. Al-Rufaie M.M. Evolution and effectiveness of colorimetric approach for investigation of ceftriaxone medicine as a pure form and in formulation vials. J. Islamic Pharm. 2018; 3(2):16. https://doi.org/10.18860/jip.v3i2.6099

40. Abdulghani A.J., Mohuee S.K. Synthesis of gold nanoparticles using ceftriaxone sodium as a reducing and stabilizing agent. Iraqi Journal of Science. 2015; 56(3C):2425.

41. Al-Rufaie M.M., Motaweq Z.Y. Estimation of Cephalosporins (Ceftriaxone, Ceftazidime) Antibiotics as Pure and Pharmaceutics Forms by Color Produced Reaction in UV-VIS Spectrophotometric Technique. J. Islamic Pharm. 2018; 3(2):1. https://doi.org/10.18860/jip.v3i2.6098

 

Volume 4, Number 58 (2020)