跳至主要内容

Application of Total Error Strategy in Validation of Affordable and Accessible UV-Visible Spectrophotometric Methods for Quality Control of Poor Medicines

Read  full  paper  at:
http://www.scirp.org/journal/PaperInformation.aspx?PaperID=53326#.VL3BYyzQrzE

ABSTRACT
In the framework of fighting against the poor quality medicines sold in developing countries using classical analytical methods easily accessible in those countries, four UV-Visible spectrophotometric methods for one antimalarial (quinine) and two antibiotics (amoxicillin and metronidazole) have been developed and validated according to the total error strategy using the accuracy profiles as a decision tool. The dosing range was 2 - 10 μg/mL (for quinine sulfate in tablet), 4 - 12 μg/mL (for quinine bichlorhydrate in oral drop-metronidazole benzaote in oral suspension) and 15 - 35 μg/mL (for amoxicillin trihydrate in capsule). The validated methods were then applied in determining the content of some analogous medicines sold in the Democratic Republic of Congo. Thus, the proposed UV-Visible spectrophotometric methods are simple and suitable to quantify quinine, amoxicillin and metronidazole in different pharmaceutical forms.
 
Cite this paper
Mbinze, J. , Mpasi, J. , Maghe, E. , Kobo, S. , Mwanda, R. , Mulumba, G. , Bolande, J. , Bayebila, T. , Amani, M. , Hubert, P. and Marini, R. (2015) Application of Total Error Strategy in Validation of Affordable and Accessible UV-Visible Spectrophotometric Methods for Quality Control of Poor Medicines. American Journal of Analytical Chemistry, 6, 106-117. doi: 10.4236/ajac.2015.62010.
 
References
[1]Hay, S.I., Guerra, C.A., Tatem, A.J., Noor, A.M. and Snow, R.W. (2004) The Global Distribution and Population at Risk of Malaria: Past, Present and Future. The Lancet Infectious Diseases, 4, 327-336.
http://dx.doi.org/10.1016/S1473-3099(04)01043-6
 
[2]Ambroise, T. (2000) Traitement du paludisme: Prévenir les résistances par les associations d’antipaludiques. Médecine Tropicale, 60, 219-222.
 
[3]Geyer, G. (2001) Les combinaisons thérapeutiques antipaludiques: Rapport d’une consultation technique. Organisation Mondiale de la Santé (World Health Organization), Genève, Suisse, 5-24.
 
[4]Mutabingwa, T., Anthony, D., Heller, A., Hallett, R., Ahmed, J., Drakeley, C., Greenwood, B.M. and Whitty, C. (2005) Amodiaquine Alone, Amodiaquine + Sulfadoxinepyrimethamine, Amodiaquine + Artesunate, and Artemether-Lumefantrine for Outpatient Treatment of Malaria in Tanzanian Children: A Four-Arm Randomized Effectiveness Trial. The Lancet, 365, 1474-1480.
http://dx.doi.org/10.1016/S0140-6736(05)66417-3
 
[5]Tall, A., Rabarijaona, L., Robert, V., Bedja, S., Ariey, F. and Randrianarivelojosia, M. (2007) Efficacy of Artesunate plus Amodiaquine, Artesunate plus Sulfadoxine-Pyrimethamine and Chloroquine plus Sulfadoxine-Pyrimethamine in Patients with Uncomplicated Plasmodium Falciparum in the Comoros Union. Acta Tropica, 102, 176-181.
http://dx.doi.org/10.1016/j.actatropica.2007.03.004
 
[6]Van Vugt, M., Looareesuwan, S., Wilairatana, P., McGready, R., Villegas, L., Gathmann, I., Mull, R., Brockman, A., White, N.J. and Nosten, F. (2000) Artemether-Lumefantrine for the Treatment of Multidrug-Resistant Falciparum Malaria, Transactions of the Royal. Society of Tropical Medicine and Hygiene, 94, 545-548.
http://dx.doi.org/10.1016/S0035-9203(00)90082-8
 
[7]South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) Group (2005) Artesunate versus Quinine for Treatment of Severe Falciparum Malaria: A Randomised Trial. Lancet, 366, 717-725.
http://dx.doi.org/10.1016/S0140-6736(05)67176-0
 
[8]Panusa, A., Multari, G., Incarnato, G. and Gagliardi, L. (2007) High-Performance Liquid Chromatography Analysis of Anti-Inflammatory Pharmaceuticals with Ultraviolet and Electrospray-Mass Spectrometry Detection in Suspected Counterfeit Homeopathic Medicinal Products. Journal of Pharmaceutical and Biomedical Analysis, 43, 1221-1227.
http://dx.doi.org/10.1016/j.jpba.2006.10.012
 
[9]Newton, P.N., Lee Sue, J., Goodman, C., Fernández Facundo, M., Yeung, S., Phanouvong, S., Kaur, H., Amin, A.A., Whitty, C.J.M., Kokwaro, G.O., Lindegårdh, N., Lukulay, P., White, L.J., Day, N.P.J., Green, M.D. and White, N.J. (2009) Guidelines for Field Surveys of the Quality of Medicines: A Proposal. PloS Medicine, 6, 0252-0257.
 
[10]Mazière, M. (2007) Pharmaceutiques, Dossier Contrefaçon. PR Editions, Tour Ariane 5-7 place de la Pyramide 92080 La Défense, Cedex, France, 68-73.
 
[11]Newton, P.N., Dondorp, A., Green, M., Mayxay, M. and White, N.J. (2003) Counterfeit Artesunate Antimalarials in Southeast Asia. The Lancet, 362, 169.
http://dx.doi.org/10.1016/S0140-6736(03)13872-X
 
[12]Caporal-Gauthier, J., Nivet, J.M., Algranti, P., Guilloteau, M., Histe, M., Lallier, M., N’guyen-Huu, J.J. and Russoto, R. (1992) Guide de validation analytique, Rapport d’une commission SFSTP, I Méthodologie. STP Pharma Pratiques, 2, 205-226.
 
[13]Notes explicative III/844/87-FR (1989) Commission des Communautés Européennes. Groupe de travail du Comité des spécialités pharmaceutiques, Bruxelles-Luxembourg, 8.
 
[14]Text on Validation of Analytical Procedures: Definitions and Terminology (Q2A) (2005) Tripartite International Conference on Harmonization (ICH) Text. ICH Technical Coordination, Londres.
 
[15]Text on Validation of Analytical Procedures: Methodology (Q2B) (2005) Tripartite International Conference on Harmonization (ICH) Text. ICH Technical Coordination, Londres.
 
[16]Vessman, J. (1996) Selectivity or Specificity? Validation of Analytical Methods from the Perspective of an Analytical Chemist in the Pharmaceutical Industry. Journal of Pharmaceutical and Biomedical Analysis, 14, 867-869.
http://dx.doi.org/10.1016/0731-7085(95)01679-1
 
[17]Food and Drug Administration (1995) International Conference on Harmonization: Guideline on Validation of Analytical Procedures: Definitions and Terminology. Federal Register, 60, 11260-11262.
 
[18]Food and Drug Administration (1997) International Conference on Harmonization: Guideline on Validation of Analytical Procedures: Methodology. Federal Register, 62, 27463-27467.
 
[19]Chapuzet, E., Mercier, N., Bervoas-Martin, S., Boulanger, B., Chevalier, P., Chiap, P., Granjean, D., Hubert, P., Lagorce, P., Lallier, M., Laparra, M.C., Laurentie, M. and Nivet, J.C. (1997) Méthodes chromatographiques de dosage dans les milieux biologiques: Stratégie de validation. STP Pharma Pratiques, 7, 169-194.
 
[20]Hubert, Ph., Chiap, P., Crommen, J., Boulanger, B., Chapuzet, E., Mercier, N., Bervoas-Martin, S., Chevalier, P., Grandjean, D., Lagorce, P., Lallier, M., Laparra, M.C., Laurentie, M. and Nivet, J.C. (1999) The SFSTP Guide on the Validation of Chromatographic Methods for Drug Bioanalysis: From the Washington Conference to the Laboratory. Analytica Chimica Acta, 391, 135-148.
http://dx.doi.org/10.1016/S0003-2670(99)00106-3
 
[21]Feinberg, M. and Raguènès, N. (1999) Development and Application of a Standardized Validation Procedure for Food Chemistry Laboratories. Analytica Chimica Acta, 391, 239-252.
http://dx.doi.org/10.1016/S0003-2670(99)00120-8
 
[22]Ermer, J. (2001) Validation in Pharmaceutical Analysis. Part I: An Integrated Approach. Journal of Pharmaceutical and Biomedical Analysis, 24, 755-767.
http://dx.doi.org/10.1016/S0731-7085(00)00530-6
 
[23]Hubert, P., Nguyen-Huu, J.J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P.A., Dewé, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C. and Valat, L. (2003) Validation des procédures analytiques quantitatives: Harmonisation des démarches. STP Pharma Pratiques, 13, 101-138.
 
[24]Boulanger, B., Chiap, P., Dewé, W., Crommen, J. and Hubert, Ph. (2003) An Analysis of the SFSTP Guide on Validation of Chromatographic Bioanalytical Methods: Progresses and Limitations. Journal of Pharmaceutical and Biomedical Analysis, 32, 753-765.
http://dx.doi.org/10.1016/S0731-7085(03)00182-1
 
[25]United States Pharmacopeial Convention (2009) USP Monographs, United States Pharmacopeial Convention 37, National Formulary 32, Rockville, MD, USA.
 
[26]Mee, R. (1988) Estimation of the Percentage of a Normal Distribution Lying Outside a Specified Interval. Communications in Statistics: Theory and Methods, 17, 1465-1479.
 
[27]Marini, R.D., Chiap, P., Boulanger, B., Rozet, E., Rudaz, S., Crommen, J. and Hubert, Ph. (2006) LC Method for the Determination of R-Timolol in S-Timolol Maleate: Validation of Its Ability to Quantify and Uncertainty Assessment. Talanta, 68, 1166-1175.
http://dx.doi.org/10.1016/j.talanta.2005.07.026                                                             eww150120lx
标签：

评论

发表评论

此博客中的热门博文

Electron Spin and Proton Spin in the Hydrogen and Hydrogen-Like Atomic Systems

Read full paper at: http://www.scirp.org/journal/PaperInformation.aspx?PaperID=52202#.VIj7tMnQrzE Author(s) Stanisław Olszewski * Affiliation(s) Institute of Physical Chemistry, Polish Academy of Sciences, Warsaw, Poland . ABSTRACT The mechanical angular momentum and magnetic moment of the electron and proton spin have been calculated semiclassically with the aid of the uncertainty principle for energy and time. The spin effects of both kinds of the elementary particles can be expressed in terms of similar formulae. The quantization of the spin motion has been done on the basis of the old quantum theory. It gives a quantum number n = 1/2 as the index of the spin state acceptable for both the electron and proton ...
发表评论
阅读全文

Incorporation of High-Altitude Balloon Experiment in High School Science Classrooms

High-altitude balloon is a balloon, filled usually with helium or hydrogen that ascends into an area called “near space” or stratosphere. The most common type of high-altitude balloons are weather balloons. Other purposes include use as a platform for experiments in the upper atmosphere. Modern balloons generally contain electronic equipment such as radio transmitters, cameras, or satellite navigation systems, such as GPS receivers. The mission of the High-Altitude Balloon Experiment (HABE) is to acquire supporting data, validate enabling technologies, and resolve critical acquisition, tracking, and pointing (ATP) and fire control issues in support of future space-based precision pointing experiments. The use of high-altitude balloons offers a relatively low-cost, low-vibration test platform, a recoverable and reusable payload, worldwide launch capability, and a 'near- space' emulation of the future space systems operational scenarios. More recently, several university...
1 条评论
阅读全文

Remarks on the Complexity of Signed k-Domination on Graphs

Read  full  paper  at: http://www.scirp.org/journal/PaperInformation.aspx?PaperID=53574#.VMnXsCzQrzE Author(s)    Chuan-Min Lee 1 , Cheng-Chien Lo 1 , Rui-Xin Ye 2 , Xun Xu 2 , Xiao-Han Shi 2 , Jia-Ying Li 2 Affiliation(s) 1 Department of Computer and Communication Engineering, Ming Chuan University, The First American University in Asia, Taoyuan, Taiwan, Chinese Taipei . 2 Department of Electronic Information Engineering, Fuzhou University, Fuzhou, China . ABSTRACT This paper is motivated by the concept of the signed k-domination problem and dedicated to the complexity of the problem on graphs. For any fixed nonnegative integer k, we show that the signed k-domination problem is NP-complete for doubly chordal graphs. For strongly chordal graphs and distance-hereditary graphs, we show that the signed k-domination problem can be solved in polynomial time. We also show that the problem is linear-time solvable for trees, interval graphs, and chord...
发表评论
阅读全文