Development and validation of stability indicating chromatographic methods for simultaneous determination of citicoline and piracetam.
citicoline
green method
piracetam
ultra high liquid chromatography
Journal
Journal of separation science
ISSN: 1615-9314
Titre abrégé: J Sep Sci
Pays: Germany
ID NLM: 101088554
Informations de publication
Date de publication:
Aug 2020
Aug 2020
Historique:
received:
25
03
2020
revised:
06
05
2020
accepted:
09
05
2020
pubmed:
21
5
2020
medline:
24
6
2021
entrez:
21
5
2020
Statut:
ppublish
Résumé
Citicoline and piracetam were subjected separately to different stress conditions as recommended by the international conference on harmonization. In addition, new stability indicating thin layer chromatographic and ultra high performance liquid chromatographic methods have been developed and validated for simultaneous determination of citicoline and piracetam in presence of their degradation products. Separation on the proposed thin layer chromatographic method was carried out using a developing system containing methanol:chloroform:ammonium chloride buffer (9:1:2, v/v/v) on silica gel plates at 230 nm. On the other hand, the mobile phase in the ultra high performance liquid chromatographic method was composed of water (containing 0.1% triethylamine):ethanol (92:8, v/v). The flow rate was 1 mL/min and ultraviolet detection was at 230 nm. Moreover, results of the developed methods were statistically compared to those obtained by the reported high-performance liquid chromatography method and no significant difference between them was found. The greenness profile of ultra high performance liquid chromatographic method was assessed and compared with those of the previously published high-performance liquid chromatography methods, it was noticed that the proposed ultra high performance liquid chromatographic method more environmentally friendly and greener than other methods.
Identifiants
pubmed: 32431004
doi: 10.1002/jssc.202000346
doi:
Substances chimiques
Tablets
0
Cytidine Diphosphate Choline
536BQ2JVC7
Piracetam
ZH516LNZ10
Types de publication
Journal Article
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
2981-2988Informations de copyright
© 2020 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Références
Budavaried S., The Merck Index: An Encyclopedia of Chemicals, Drugs and Biological. Wiley, Whitehouse station, NJ, 2006.
Brayfield A., Martindale: The Complete Drug Reference. Pharmaceutical Press, London, UK, 2012.
Mahmoud O. A., Hegazy M. A., Salem H., Moustafa A. A., Comparative study of reversed-phase high-performance liquid chromatography versus thin-layer chromatography-densitometry for determination of citicoline sodium in presence of its alkaline degradation products. J. Planar Chromatogr. 2015, 28, 241-247.
Patel J. A., Panigrahi B., Patel C. N., Ramalingan B., Stress degradation studies on citicoline sodium and development of a validated stability-indicating HPLC assay. Chron. Young Sci. 2011, 2, 150-154.
Bindaiya S. K., Sahu K., Bhaisare M., Karthikeyan C., Moorthy N. S. H. N., Mehta F. F., Trivedi P., Development and validation of a RP-HPLC method for determination of citicoline monosodium in human plasma. Latin Amer. J. Pharm. 2011, 30, 794-798.
Maradiya H. K., Pansara V. H., Development and validation of reverse-phase high-performance liquid chromatography method for estimation of citicoline sodium in bulk and dosage form. Indian J. Pharm. Sci. 2013, 75, 238-241.
Sharma O., Chand T., Analytical method development and its validation for estimation of citicoline sodium by reversed phase high performance liquid chromatography (RP-HPLC). Int. J. Res. Pharm. Biomed. Sci. 2013, 4, 550-558.
Surani S., Kabra P., Kimbahune R., Sunil K., Nargund L. V., A reverse phase liquid chromatography analysis of citicoline sodium in pharmaceutical dosage form using internal standard method. Int. J. Pharm. Tech. Res. 2012, 4, 1136-1141.
Sandhya S., Jyothisree G., Babu G., Development of a validated RP-HPLC method for the analysis of citicoline sodium in pharmaceutical dosage form using internal standard method. Int. J. Pharm. Res. Review. 2014, 3, 20-25.
Ganduri R. B., Peddareddigari J. R., Dasari N. R., Saiempu R. K, Stability indicating LC method for the determination of citicoline sodium in injection formulation. Int. J. Pharm. Tech. Res. 2010. 2, 427-33.
Medicines and Healthcare Products Regulatory Agency, The British Pharmacopoeia. Medicines and Healthcare Products Regulatory Agency, London, UK, 2013.
European Directorate for the Quality of Medicines, European Pharmacopoeia. Council of Europe, Strasbourg, 2002.
Ovalles J. F., Tettey J. N. A., Miller J. M., Skellern G. G., Determination of piracetam and its impurities by TLC. J. Pharm. Biomed. Anal. 2000, 23, 757-761.
Metwally F. H., Elzeany B. A., Darwish H. W., New methods for determination of cinnarizine in mixture with piracetam by spectrodensitometry, spectrophotometry, and liquid chromatography. J. AOAC Int. 2005, 88, 1666-1676.
Dwi Lestari A., Tri Prasetyo A., Palupi T., Umayah E., Yuwono M. and Indrayanto G., HPLC Determination of piracetam in tablets; Validation of the method. J. Liq. Chromatogr. Relat. Technol. 2005, 28, 1407-1416.
Navaneethan G., Karunakaran K., Elango K. P., Stability indicating and simultaneous determination of cinnarizine and piracetam from capsule dosage form by reversed phase high performance liquid chromatography. Ind. J. Chem. Technol. 2013, 20, 323-326.
El-Gindy A., Emara S., Mostafa A., Spectrophotometric and LC determination of two binary mixtures containing antihistamins. Il Farmaco. 2004, 59, 713-722.
El-Houssini O. M., Zawilla N. H., Mohammad M. A., Development and validation of RP-LC method for the determination of cinnarizine/piracetam and cinnarizine/heptaminol acefyllinate in presence of cinnarizine reported degradation Products. Anal. Chem. Insights. 2013, 8, 99-106.
Ahmed A. B., Abdelrahman M. M., Abdelwahab N. S., Salama F. M., Stability-indicating TLC-Densitometric and HPLC methods for the simultaneous determination of piracetam and vincamine in the presence of their degradation products. J. AOAC Int. 2016, 99, 1490-1498.
El-Saharty Y. S. I., Simultaneous determination of piracetam and vincamine by spectrophotometric and high-performance liquid chromatographic methods. J. AOAC Int. 2008, 91, 311-321.
Mittal A., Parmar S., Gilani S. J., Imam S. S., Taleuzzaman M., Optimization and Validation for Simultaneous Estimation of Citicoline and Piracetam in bulk and tablet formulations using RP-HPLC method: Analytical quality by design approach. Asian J. Res. Chem. 2017, 10, 198-205.
Acharya M., Jain A. K., Sharma N., Jain S., Saluja G.S., Dixit A., RP-HPLC method development and validation for simultaneous determination of citicoline and piracetam in pharmaceutical dosage form. Indo American J. Pharm. Res. 2015, 5, 3639-3647.
Panda S. S., Ravi Kumar B. V. V., Mohanta G., Panda J., Reverse phase ultra fast liquid chromatography method for simultaneous estimation of citicoline sodium and piracetam in tablets. Int. J. Pharm. Sci. Nanotech. 2013, 6, 1952-1957.
Capello C., Fischer U., Hungerbühler K., What is a green solvent? A comprehensive framework for the environmental assessment of solvents. Green Chem. 2007, 9, 927-934.
Young J. L., Raynie D. E., Replacement of hazardous solvents and reagents in analytical chemistry, in Challenges in Green Analytical Chemistry. Royal Soc. Chem. Camb. 2011, 13, 44-62.
Keith L. H., Gron L. U., Young J. L., Green analytical methodologies. Chem. Reviews. 2007, 107, 2695-2708.
Namieśnik, J., Green analytical chemistry-some remarks. J. Sep. Sci. 2001, 24, 151-153.
Elzanfaly E. S., Hegazy M. A., Saad S. S., Salem M. Y., Fattah L. E. A. E., Validated green high-performance liquid chromatographic methods for the determination of coformulated pharmaceuticals: A comparison with reported conventional methods. J. Sep. Sci. 2015, 38, 757-763.
International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use, ICH harmonised tripartite guideline: validation of analytical procedures: text and methodology Q2(R1), 2005.