Jump to ContentJump to Main Navigation
Show Summary Details
More options …

Macedonian Veterinary Review

The Journal of the Faculty of Veterinary Medicine-Skopje at the Ss. Cyril and Methodius University in Skopje

2 Issues per year


CiteScore 2016: 0.28

SCImago Journal Rank (SJR) 2016: 0.161
Source Normalized Impact per Paper (SNIP) 2016: 0.368

Open Access
Online
ISSN
1857-7415
See all formats and pricing
More options …

Preliminary Investigation of the Possibility for Implementation of Modified Pharmacopoeial HPLC Methods For Quality Control Of Metronidazole And Ciprofloxacin In Medicinal Products Used In Veterinary Medicine

Marjan Piponski
  • Corresponding author
  • Pharmaceutical Company Replek Farm Ltd., Quality Control Department st. Kozle 188, 1000 Skopje
  • Replek Farm Ltd., Quality Control Department st. Kozle 188, Skopje, Republic of Macedonia
  • Email:
/ Tanja Bakovska
  • Pharmaceutical Company Replek Farm Ltd., Quality Control Department st. Kozle 188, 1000 Skopje
/ Marina Naumoska
  • Pharmaceutical Company Replek Farm Ltd., Quality Control Department st. Kozle 188, 1000 Skopje
/ Tatjana Rusevska
  • Pharmaceutical Company Replek Farm Ltd., Quality Control Department st. Kozle 188, 1000 Skopje
/ Gordana Trendovska Serafimovska
  • Pharmaceutical Company Replek Farm Ltd., Quality Control Department st. Kozle 188, 1000 Skopje
/ Hristina Andonoska
  • Pharmaceutical Company Replek Farm Ltd., Quality Control Department st. Kozle 188, 1000 Skopje
Published Online: 2015-11-18 | DOI: https://doi.org/10.14432/j.macvetrev.2014.11.029

Abstract

Quality control of veterinary medicine products containing two different frequently used antibiotics metronidazole and ciprofloxacin hydrochloride, was considered and performed, using modified pharmacopoeial HPLC methods. Three different HPLC systems were used: Varian ProStar, Perkin Elmer Series and UPLC Shimadzu Prominence XR. The chromatographic columns used were LiChropher RP Select B 75 mm × 4 mm with 5 μm particles and Discovery C18 100 mm × 4,6 mm with 5 μm particles. Chromatographic methods used for both analytes were compendial, with minor modifications made for experimental purposes. Minor modifications of the pharmacopoeia prescribed chromatographic conditions, in both cases, led to better chromatographic parameters, good resolution and shorter analysis times. Optimized methods can be used for: determination of metronidazole in gel formulation, for its simultaneous quantification with preservatives present in the formulation and even for identification and quantification of its specified impurity, 2-methyl-5-nitroimidazole; determination of ciprofloxacin hydrochloride in film coated tablets and eye drops and identification and quantification of its specified impurities. These slightly modified and optimized pharmacopoeial methods for quality control of metronidazole and ciprofloxacin dosage forms used in veterinary medicine can be successfully applied in laboratories for quality control of veterinary medicines.

Keywords: metronidazole; ciprofloxacin hydrochloride; veterinary medicines; pharmacopoeia; quality control

References

  • 1. Official Journal of European Union. Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits of foodstuffs of animal origin. Pub. L. No. 15/72 (January 20, 2010).Google Scholar

  • 2. WedgewoodPetRx.com [Internet]. New Jersey (USA): Wedgewood Pharmacy; c2004-13 [cited 2014 May 04]. Available from: http://www.wedgewoodpetrx.com/Google Scholar

  • 3. PetMD [Internet]. Pennsylvania (USA): Pet360, Inc.; c1999-2014 [cited 2014 May 04]. Available from: http://www.petmd.com/Google Scholar

  • 4. Official Journal of European Communities. Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. Pub. L. No. 311/1-66 (November 28, 2001).Google Scholar

  • 5. Official Journal of European Communities. Directive 2004/28/EC of the European Parliament and of the Council of 31 March 2004 on the Community code relating to veterinary medicinal products. Pub. L. No. 136/58-84 (April 30, 2004).Google Scholar

  • 6. Veterinary EU Legislation: Medicines [Internet]. Brussels (EU): Federation of Veterinarians of Europe (FVE); c2014 [cited 2014 May 07]. Available from: http://www.fve.org/veterinary/medicines.php#1Google Scholar

  • 7. Veterinary medicines: regulatory information [Internet]. London (UK): European Medicines Agency; c1995-2014 [cited 2014 May 07]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl= pages/regulation/landing/veterinary_medicines_ regulatory.jsp&mid=Google Scholar

  • 8. British Pharmacopoeia Commission. British Pharmacopoeia (Veterinary) 2012. Norwich: The Stationery Office; 2011.Google Scholar

  • 9. China Veterinary Pharmacopoeia Commission. Veterinary Pharmacopoeia of the People’s Republic of China. 2010 ed. Beijing: China Agriculture Press; 2010.Google Scholar

  • 10. Indian Pharmacopoeia 2014: Veterinary monographs. 7th ed. Raj Nagar, Ghaziabad: Indian Pharmacopoeia Commission; 2014.Google Scholar

  • 11. European Pharmacopoeia. 7th ed. Strasbourg: European Directorate for the Quality of Medicines - Council of Europe; 2010-2012.Google Scholar

  • 12. British Pharmacopoeia Commission. British Pharmacopoeia 2012. Norwich: The Stationery Office; 2011.Google Scholar

  • 13. United States Pharmacopeia and National Formulary (USP 33-NF 28). Rockville: United States Pharmacopeia Convention; 2009.Google Scholar

  • 14. Society of Japanese Pharmacopoeia. Japanese Pharmacopoeia. 16th ed. Tokyo: Maruzen Company, Ltd.; 2012.Google Scholar

  • 15. The International Pharmacopoeia. 4th ed. Geneva: World Health Organization; 2006.Google Scholar

  • 16. Product Monograph. Flagyl® (Metronidazole) 10% w/w Cream, 500 mg Capsules. Quebec: Sanofi- Aventis Canada Inc.; 2013.Google Scholar

  • 17. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; ICH Harmonised Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2(R1), Current Step 4 version, Parent Guideline dated 27 October 1994 [cited 2014 Oct 07]. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_ Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1__ Guideline.pdfGoogle Scholar

  • 18. Tashtoush, BM., Jacobson, EL., Jacobson, MK. (2008). Validation of a simple and rapid HPLC method for determination of metronidazole in dermatological formulations. Drug Dev Ind Pharm. 34(8): 840-844. http://dx.doi.org/10.1080/03639040801928598 PMid:18618307CrossrefWeb of ScienceGoogle Scholar

  • 19. Melikyan, AL., Martirosyan, SS., Grigoryan, SR., Topchyan, VH., Davtyan, KT. (2013). Development and validation of HPLC method for the determination of metronidazole benzoate and related impurities in bulk and pharmaceutical formulations. IJPSR. 4(7): 2594-2599. Google Scholar

About the article

Received: 2014-06-03

Revised: 2014-09-25

Accepted: 2014-11-10

Published Online: 2015-11-18

Published in Print: 2015-03-01


Citation Information: Macedonian Veterinary Review, ISSN (Online) 1857-7415, DOI: https://doi.org/10.14432/j.macvetrev.2014.11.029.

Export Citation

© 2015. This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License. BY-NC-ND 4.0

Comments (0)

Please log in or register to comment.
Log in