全部 标题 作者
关键词 摘要

OALib Journal期刊
ISSN: 2333-9721
费用:99美元

查看量下载量

相关文章

更多...

Influence of Some Physicochemical Exposure Factors on the Metronidazole Content of a Pharmaceutical Product: Flagyl? 250 mg Tablet

DOI: 10.4236/ojpc.2022.123003, PP. 31-45

Keywords: Metronidazole, Influence, Physicochemistry, Content, Stability

Full-Text   Cite this paper   Add to My Lib

Abstract:

The present work aims to study the influence of some physicochemical parameters (light, temperature, ethanol, bile salts, potassium hydroxide, hydrogen peroxide) on the content of Metronidazole (MTZ) contained in the reference substance (SR) and in a pharmaceutical specialty Flagyl® 250 mg tablet (FLG). The method developed was linear and accurate in accordance with USP 38 and the MTZ contents were obtained by UV-visible spectrophotometry at 278 nm. These contents ranged from 225 mg to 275 mg and were thus consistent with the concentration present in the proprietary medicines (250 mg). The study of the influence of physicochemical parameters on the MTZ content in SR and FLG showed that MTZ contents are unstable in the presence of Ethanol at 96˚, KOH at 0.1N and bile salts but also when the temperature is higher than 25˚C. However, they remain stable in the presence of light and H2O2 and undergo degradation in an acidic environment.

References

[1]  World Health Organization WHO (2008) Marketing Authorization of Medicines for Human Use, Including Multi-Source (Generic) Medicines: A Manual for Pharmaceutical Regulatory Authorities. Pharmaceutical Regulation Series No. 13, 236.
[2]  Durafour, P.-A. (2020) The Importance of Stability Studies in the Pharmaceutical Field: Quality, Regulation and General Process. Doctor’s Thesis, University, Faculty of Pharmacy, Lyon, 23.
[3]  World Health Organization WHO (2008) Quality Assurance of Medicines: WHO’s Normative Role in Products. WHO/HIS/EMP HIS/EMP [Communication] 30, 1-46.
[4]  Moken, M.C. (2003) Fake Pharmaceuticals: How They and Relevant Legislation or Lack Thereof Contribute to Consistently High and Increasing Drug Prices. American Journal of Law & Medicine, 29, 525.
https://doi.org/10.1017/S0098858800002598
[5]  Newton, P.N., Green, M.D., Fernández, F.M., Day, N.P. and White, N.J. (2006) Counterfeit Anti-Infective Drugs. The Lancet Infectious Diseases, 6, 602-613.
https://doi.org/10.1016/S1473-3099(06)70581-3
[6]  Kelesidis, T., Kelesidis, I., Rafailidis, P.I. and Falagas, M.E. (2007) Counterfeit or Substandard Antimicrobial Drugs: A Review of the Scientific Evidence. Journal of Antimicrobial Chemotherapy, 60, 214-236.
https://doi.org/10.1093/jac/dkm109
[7]  Singer, R.S., Finch, R., Wegener, H.C., Bywater, R., Walters, J. and Lipsitch, M. (2003) Antibiotic Resistance—The Interplay between Antibiotic Use in Animals and Human Beings. The Lancet Infectious Diseases, 3, 47-51.
https://doi.org/10.1016/S1473-3099(03)00490-0
[8]  Netto Cde, G. and Miyata, C.C. (1966) Treatment of Vaginal Trichomoniasis with Metronidazole, Flagyl, in Gel Form. Preliminary Results. Canadian Medical Association Journal, 70, 447-449.
[9]  Dupouy-Camet, J. (2004) New Drugs for the Treatment of Human Parasitic Protozoa. Parassitologia, 46, 81-84.
[10]  N’dri-Yoman, A., Yao-Bathaix, M., Attia, K., Mahassadi, A. and Madougou, B. (2006) Treatment and Evolutionary Profile of Amoebic Liver Abscesses: At the Hospital and University Centre of Yopougon (RCI). Médecine Afrique Noire, 53, 87-92.
[11]  Bernadette, D.T.F., Valérie, C.G.M., Nathalie, G., Francis, Y.A., Solange, K.N. and Aboulaye, O. (2017) Molecular Detection of Antibiotic Resistance of Helicobacter pylori from Gastric Biopsies in Abidjan (Ivory Coast). Microbiology Research Journal International, 20, 1-7.
https://doi.org/10.9734/MRJI/2017/32912
[12]  Kouassi, K.A., Dadie, A.T., N’Guessan, K.F., Dje, K.M. and Loukou, Y.G. (2014) Clostridium Perfringens and Clostridium difficile in Cooked Beef Sold in Cote d’Ivoire and Their Antimicrobial Susceptibility. Anaerobe, 28, 90-94.
https://doi.org/10.1016/j.anaerobe.2014.05.012
[13]  USP 38-NF 33 The United States Pharmacopeia and National Formulary Version 2015 Main Edition plus Supplements 1 and 2. Deutscher Apotheker Verlag, Gerlingen.
[14]  Das, J. and Dhua, M. (2014) UV-Spectrophotometric Assay Method Development and Validation of Metronidazole in Bulk and Tablet Formulation. Journal of Pharmaceutical Science and Technology, 3, 106-109.
[15]  Mastanamma, S., Sravani, K. and Anil, T. (2015) UV Differential Spectrophotometric Method for the Estimation of Metronidazole in Bulk and Pharmaceutical Formulation. Rasayan Journal of Chemistry, 8, 303-309.
[16]  Sadek, S.A., Abbar, R.S., Atia, Z.A.M., Diaa, L.M., Naif, H.J., Jafar, K.F., Essam, Z., Sadoon, R., Ayad, R. and Kareem, G. (2020) Comparative of Chemical Methods for Determination Metronidazole—A Review. 5th Grade, Second Semester, Report, Mustansiriyah University, College of Pharmacy, Department of Pharmaceutical Chemistry, Baghdad, 5.
[17]  ANSM (2019) Summary of Product Characteristics.
http://agence-prd.ansm.sante.fr/php/ecodex/rcp/R0240905.htm
[18]  Arun, K.M., Arvind, K., Amrita, M. and Hari, V.M. (2014) Development of an Ultraviolet Spectroscopic Method for the Estimation of Metronidazole Benzoate from a Pharmaceutical Formulation. Journal of Natural Science, Biology and Medicine, 5, 261-264.
https://doi.org/10.4103/0976-9668.136154
[19]  Ebeed, F.M.A.B. (2016) Effect of Heat, Sun Light and Acidity on Metronidazole and Metronidazole Benzoate Using UV Spectroscopy in Chemical Engineering Technology Faculty of Engineering and Technology. Master’s Dissertation, The University of Gezira, Wad Madani, 42.
[20]  Van Bambeke, F. and Pharm, S. (2008) Pharmacology and Anti-Infective Pharmacotherapy. Syllabus Natl Belge Pharmacol. 2008, 1-134.
[21]  Naveed, S., Waheed, N. and Nazeer, S. (2014) Degradation Study of Metronidazole in Active and Different Formulation by UV Spectroscopy. Journal of Bioequivalence & Bioavailability, 6, 124-127.
https://doi.org/10.4172/jbb.10000191

Full-Text

Contact Us

service@oalib.com

QQ:3279437679

WhatsApp +8615387084133