Transfer, Validation and Application of HPLC Analytical Method for Simultaneous Determination of Paracetamol and Diclofenac in Tablets

Authors

  • Emile Tweni Baruti Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Kisangani, Democratic Republic of Congo
  • Jérémie Mbinze Kindenge Drug Analysis Laboratory, Department of Galenics and Drug Analysis, Faculty of Pharmaceutical Sciences, University of Kinshasa, Democratic Republic of Congo
  • Issa Yakusu Issa Department of Internal Medicine, Faculty of Medicine and Pharmacy, University of Kisangani, Kisangani, Democratic Republic of the Congo
  • Marguerite Borive Amani Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Kisangani, Democratic Republic of Congo
  • Elodie Nsasi Bankiantima Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Kisangani, Democratic Republic of Congo
  • Justin Ntokamunda Kadima Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Kisangani, Democratic Republic of Congo
  • Roland Marini Djangeing’a Department of Pharmacy, Faculty of Medicine and Pharmacy, University of Kisangani, Democratic Republic of Congo

DOI:

https://doi.org/10.53555/bp.v7i3.1548

Keywords:

Paracetamol, Diclofenac, Tablets, HPLC, Geometric transfer, Validation, Optimization

Abstract

Various pharmaceutical preparations containing paracetamol in combination with other nonsteroidal anti-inflammatory drugs are produced for the treatment of postoperative pain management. A lack of selective analytical techniques makes it difficult to fully assay all incorporatedactive ingredients. An original HPLC method developed at the University of Liège for the assay of the paracetamol-diclofenac combination in tabletshas been transferred and validated at the University of Kisangani for its application locally. The use of an Xbridge® column (C18, 100 x 4.6 mm/3.5µm) instead of Xbridge® (C18, 250 x 4.6mm/5µm) allowed to reduce the time of analysis from 60 min to 20 min, as well as the consumption of methanol in the mobile phase, while maintaining the efficiency and selectivity of the original method. After validation the method was applied for the analysis of two generics marked in the city. The tranferedmethod allows an appreciable saving in time and in the solvent economy to be applied in routine for quality control of  generics in circulation.

Downloads

Download data is not yet available.

References

Daniela. Le point par l’OMS sur les médicaments de qualité inférieure et contrefaits- Bagozzi, Mai 2004.

Habyalimana V, Kalenda TN, Dispas A, Mbinze JK, J.L. Kadima N, Lebrun P, Hubert P, Marini RD. Méthodes chromatographiques génériques de criblage pour lutter contre les médicaments de qualité inférieure. Spectra anal, 298, 2014, 30-36.

Mbinze JK. développement de méthodes génériques pour le dosage des médicaments commercialises sur le marché congolais : utilisation de méthodes séparatives et non séparatives, thèse de doctorat, Université de Liège, Belgique, 2015

Aweke Z, SeyoumF ,Shitemaw T, Doba DN. Comparison of preemptive paracetamol, paracetamol-diclofenac & paracetamol-tramadol combination on postoperative pain after elective abdominal surgery under general anesthesia, Ethiopia: a randomized control trial study, 2018. BMC Anesthesiol. 2020 Aug 4;20(1):191. doi: 10.1186/s12871-020-01115-6.

Mbinze JK, Lebrun P, Debrus B, Dispas A, Kalenda N, J. Mavar TM, Schofield T, Boulanger B, Rozet E, Hubert P, Marini RD. Application of an innovative design space optimization strategy to the development of liquid chromatographic methods to combat potentially counterfeit nonsteroidal anti-inflammatory drugs, J. Chromatogr. A, 1263, 2012, 113–124.

Guillarme D, Nguyen D, Rudaz S, Veuthey JL. Method Transfer for Fast Liquid Chromatography in Pharmaceutical Analysis: Application to Short Columns Packed with Small Particle. Part I: Isocratic Separation, Eur. J. Pharm. Biopharm, 66, 2007, 475-482.

Hubert P, Nguyen-Huu JJ, Boulanger B, Chapuzet E, Cohen N, Compagnon PA, Dewé W, Feinberg M, Laurentie M , Mercier N, Muzard G, Valat L , Rozet E. Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal–Part III, J. Pharm. Biomed. Anal., 45, 2007, 82-96.

Debrus B, Lebrun P, Kindenge JM, Lecomte F, Ceccato A , Caliaro G, Mbay JM, Boulanger B, Marini RD, Rozet E, Hubert P, Innovative high-performance liquid chromatography method development for the screening of 19 antimalarial drugs based on a generic approach, using design of experiments, independent component analysis and design space, J Chromatogr A, 1218, 2011, 5205-5215.

Boulanger B, Rozet E, Moonen F, Rudaz S, Hubert P. A risk-based analysis of the AAPS conference report on quantitative bioanalytical methods validation and implementation, J Chromatogr B AnalytTechnol Biomed Life Sci., 877, 2009, 2235-2243.

Downloads

Published

2021-04-30

How to Cite

Baruti, E. T. ., Kindenge, J. M. ., Issa, I. Y. ., Amani, M. B. ., Bankiantima, E. N., Kadima, J. N., & Djangeing’a, R. M. (2021). Transfer, Validation and Application of HPLC Analytical Method for Simultaneous Determination of Paracetamol and Diclofenac in Tablets. International Journal For Research In Biology & Pharmacy, 7(3), 01–05. https://doi.org/10.53555/bp.v7i3.1548