ANALYTICAL TECHNIQUES IN NEUROPHARMACOLOGY: SIMULTANEOUS DETERMINATION OF CITICOLINE SODIUM AND PIRACETAM BY UV-SPECTROSCOPY AND HIGH PERFORMANCE LIQUID CHROMATOGRAPHY

Main Article Content

Kodukula Mohana Anjani Durga
Asha Deepti Choppala

Keywords

Citicoline Sodium, Piracetam, UV- spectroscopy method, RP-HPLC, Phosphate buffer, ammonium formate buffer, Acetonitrile

Abstract

The aim of this research is to develop a UV spectrophotometric method and HPLC method that can estimate both citicoline sodium and piracetam simultaneously in pharmaceutical formulations. A phosphate buffer at pH 6.8 was chosen as the suitable medium for the analysis in the study. Citicoline sodium was found to have a concentration range of 10 to 80µ g/ml, while piracetam's concentration range was 10-80 µg/ml.


Citicoline sodium and piracetam were UV absorbed using 272nm and 207.28 nm wavelengths, with the iso-absorptive point being 219.8nm as reported in the information. The calibration curves were made and showed a linear relationship between concentration and absorbance for both compounds. Within the specified concentration ranges, the method demonstrated excellent precision and accuracy.


The UV estimation method's stability and reproducibility are improved by using a phosphate buffer at pH 6.8.A reverse phase high performance liquid chromatographic method that is simple, fast, sensitive, and validated was developed to estimate Citicoline and Piracetam simultaneously in pharmaceutical dosage forms.


The chromatographic conditions used for the separation was agilent eclipse XDB(4.6 x 250 mm x 5 μm) with mobile phase comprised of Acetonitrile: Ammonium formate pH-3.0 adjusted with OPA (20: 80).


The flow rate was determined at 1.0 ml/min and 269 nm was detected. The analysis revealed that the retention times for Citicoline and Piracetam were determined to be 5.615 and 2.258, respectively. The methodology was formulated with the aim of attaining precision, accuracy, specificity, linearity, system suitability, and stability assessments, incorporating evaluations for limits of detection, quantification, ruggedness, and robustness.


Citicoline sodium and Piracetam exhibited linearity within the ranges of 12.50 to 75.00 µg/ml and 10 to 60g/ml, respectively. All specified parameters fell within the designated limits. The methodologies proposed are deemed suitable for the concurrent analysis of Citicoline and Piracetam in pharmaceutical formulations

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References

1. Stability indicates the development and validation of a reversed-phase high-performance liquid chromatography method for the simultaneous determination of citicoline and piracetam-related substances in pharmaceutical form MANUTOSH ACHARYA1*, JAIN AK2, NAVNEET Center GARUDR&D, Omni Active Health Technologies, Thane - 400 064, Maharashtra, India 2Department of Pharmacy, Gajara Raja Medical College, Gwalior, Madhyapradesh, India. 3 School of Pharmaceutical Sciences, Jiwaji University, Gwalior, Madhyapradesh, India.
2. A comparative study of the new ratio difference method versus conventional spectrophotometric techniques for the analysis of binary mixtures with overlapping spectra Hayam M. Lotfy1, Sarah S. Saleh2*, Nagiba Y. Hassan1, Samia M. Elgizawy3 1 Department of Analytical Chemistry, Faculty of Pharmacy, Cairo University, Cairo, Egypt 2 Department of Analytical Chemistry, Faculty of Pharmacy, October University of Arts and Sciences (MSA) , course 6 October City, Egypt 3 Department of Analytical Chemistry, Faculty of Pharmacy, Assuit University, Assuit, Egypt
3. INDIAN PHARMACOPEIA 2022 VOLUME II
4. UNITED STATES PHARMACOPEIA VOLUME III
5. Development and validation of spectrophotometric methods for simultaneous estimation of citicoline and piracetam in tablet dosage form: Department of Pharmaceutical Chemistry, Amrita School of Pharmacy, Amrita Vishwa Vidyapeetham University, Kochi, Kerala, India J Pharm Bioallied Sci. 2013 Jul-Sep; 5(3): 202–207.
6. UV-Spectrophotometric Methods for Determination of Citicoline sodium and Piracetam in Pharmaceutical Formulation: Minakshi M. Dhoru*, Sanjay Surani, Priti Mehta Department of Pharmaceutical Chemistry, Shankersinh Vaghela Bapu Institute of Pharmacy, Nr. Vasaniya Mahadev, Gandhinagar-Mansa Road, Vasan, Gandhinagar- 382650, Gujarat, India.
7. Method development and validation of RP-HPLC for simultaneous estimation of citicoline and piracetam in tablet dosage form: G. Babu1 *, Prasad K1 , Thejonath Kolla1 , M. Vijayabaskaran2 , S. T. Latha3 1Department of Pharmaceutical Analysis,J. K. K. Nattraja College of Pharmacy,Komarapalayam – 638 183Namakkal Dt. Tamil Nadu.India.
8. Drug Dictionary.com Unbridge Vol.1.1, Random house 20 September 2007.
9. Similer R, Walsh G, Mattaliano RJ, Guziewicz N and Perez-Ramirez B (2008). Maximizing data collection and analysis during formulation of Biotherapeutic Proteins, Bioprocess International 6(10), 38-45.
10. Journals Ranked by Impact: Toxicology 2014. Journal Citation Reports. Web Sciences (Sciences ed.). Thomson Reuters 2015.
11. Van Tellingen C, “Pliny’s pharmacopoeia or the Roman treat, Netherlands heart journal 15(3) : 118-20, March 2007.
12. Merriam Webster dictionary, 1828.
13. World Health Organization. Working document 2011 : Defination of Active Pharmaceutical Ingredient. Geneva, Switzerland: World Health Organization; 2011.
14. Bhattacharyya, Lokesh, Schuder, Stefan, Sheehan, Catherine, William, Exipinets Background/Introduction in Katdare Ashok, Chaubal Mahesh. Excipents Development for Pharmaceutical, Biotechnology and Drug Delivery Systems 2006.
15. Juran, Joseph M, A history of Managing for Quality. The evalution, trends and future directions of managing quality. Milwaukee, Wisconsin. The American society for quality control, ed.1995.
16. Managing Quality Across the Enterprise; Enterprise Quality Management Solution for medical device companies. Sparta systems 2015-02-02.
17. Skoog Douglas A, West Donald M, Holler F, James Crouch, Stanley R. Fundamentals of Analytical chemistry, Belmont, Brokes/cole, Cengage Learning.p-1 (2014).
18. Wolf, Jakob, Schnellkurs HGB-Jahresabschluss, Das neue Bilanzrecht, Richtig vorgehen-erfolreich umstellen. Walhalla Fachverlag.p.90. 15 January 2010.
19. Chromatography Hand Book of HPLC, Katz(Wiley & Sons); page no.14-16.2002.
20. Henry Richard L, “The early days of HPLC at Dupont” chromatography online. Avanstar communications Inc. 1 February 2009.
21. IUPAC, Compendium of Chemical Terminology, 2nd ed. (the Gold Book) 1997.
22. W.John Lough, Irving W.Wainer, High performance Liquid Chromatography Fundamental principles and practice. Blackie Academic & Professional pp.120.
23. Practical HPLC method development and validation second edition Lloyd R. Synder, Jpseph J. Kirkland and Joseph L.Glaich pg no: 1-3.
24. Emer Joachim, John H, McB Miller, Method Validation in Pharmaceutical Analysis. A Guide to best practice Wiley-VCH page no. 418.
25. IUPAC, Compendium of Chemical Terminology, 2nd edition The gold book,1997.
26. Mac Dougall, Daniel, Crummett, Warren B et.al., “Guidelines for data acquisition and data quality evalution in environmental chemistry. Anal.chem.52:2242-49.
27. Method Validation; "Archived copy". Archived from the original on 11 September 2011.
28. Health Sciences Authority. "Guidance Notes on Analytical Method Validation: Methodology".
29. Heyden, Y. Vander; S.W. Smith; et al. (2001). "Guidance for robustness/ruggedness tests in method validation". Journal of Pharmaceutical and Biomedical Analysis. Elsevier. 24 (5–6): 723–753.
30. Subcommittee E11.20 on Test Method Evaluation and Quality Control (2014), Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods,
31. Lukacs, E. (1970) Characteristic Functions. Griffin, London.
32. National Council on measutement in Education Education. http://www.ncme.org/ncme/NCME/Resource_Center/Glossary/NCME/Resource_Center/Glossary.
33. Bland, J.M.; Altman, D.G. (1996). Statistics notes: measurement error. BMJ. 312 (7047): 1654.
34. FDA Issues Dietary Supplements Final Rule" (Press release). U.S. Food and Drug Administration. 2007-06-22. Retrieved 2010-06-04.
35. Kevin Robinson for BioPharm International, Aug 1, 2003. GLPs and the Importance of Standard Operating Procedures.
36. ICH Harmonised Tripartite Guideline Q2(R1), Current Step 4 version Parent Guideline; 27 October 1994.
37. Validation definition and FDA, Regulatory agencies guidelines requirement Accessed 27 Feb 2014.
38. Maha m Abdelrahman 1 2, Amal b Ahmed 2, Mahmoud a Omar 3 4, Sayed m derayea 3, nada s Abdelwahab, development and validation of stability indicating chromatographic methods for simultaneous determination of citicoline and piracetam: j sep sci 2020 aug;43(15):2981-2988.
39. G. Babu1 *, Prasad k1 , Thejonath kolla1 , M. Vijayabaskaran2 , S. T. Latha, Method development and validation of RP-HPLC for simultaneous estimation of citicoline and piracetam in tablet dosage form. international journal of pharmtech research. vol.3, no.3,pp1311-1313, july-sept 2011
40. P. Kabra L.V.G. Nargund, Srinivasa Murthy Muppavarapu, development and validation of a rp-hplc method for the quantification of citicoline and piracetam. international journal of pharmaceutical sciences review and research 16(1):111-114
41. Manutosh acharya1, Jain ak2, Navneet garud3, stability indicating reversed phase-high performance liquid chromatography method development and validation for simultaneous determination of related substances of citicoline and piracetam in pharmaceutical dosage form. asian journal of pharmaceutical and clinical research ,vol 9, issue 2, 2016
42. T.Venkatachalam1, K. G. Lalitha2, analytical method development and validation of a simultaneous determination of citicoline and piracetam at single wavelength. journal of biomedical and pharmaceutical research (jbpr) vol. 3 no. 3 (2014)