International Journal of Drug Delivery Technology
Volume 14, Issue 1

An Ecologically Sound RP-HPLC Method for Estimating Citicoline using AQbD with Degradation Studies

R Vineetha, Manikandan Krishnan*

Department of Pharmaceutical Analysis, SRM College of Pharmacy, SRM Institute of Science and Technology, Chennai, Tamil Nadu, India. 

Received: 20th December, 2023; Revised: 04th January, 2024; Accepted: 17th February, 2024; Available Online: 25th March, 2024

ABSTRACT

Background: Citicoline is widely used for neurological complications. This research work was carried out using reverse-phase high-performance liquid chromatography (RP-HPLC) employing green analytical chemistry principles.

Materials and Methods: The method was completely developed with ethanol:water (20:80 v/v) as the mobile phase, 0.1% orthophosphoric acid was used to adjust the pH to 3.5, and an Inertsil ODS 3 (250 x 4.6 mm, 5 µm) column as the stationary phase, the flow rate was set at 1-mL/min. The column temperature was maintained at 35ºC, and an injection volume of 10 μL was used for detection at a wavelength of 250 nm.

Results and Discussion: The peak was eluted with isocratic elution with a retention time of 3.996 minutes. The linear concentration range for this method was 10 to 50 µg/mL, and the correlation coefficient R2 was 0.999. The forced degradation studies have shown that 3.5% w/w degraded in acid, 1.35% w/w in alkali, and 0.2% w/w in oxidation. The products formed during degradation were characterized using gas chromatography-mass spectrometry (GC-MS).

Conclusion: The International Council for Harmonisation (ICH) guidelines were followed in the development and validation of the method optimized by the use of central composite design, and the method’s greenness was assessed through the use of AGREE, AES, GAPI, and AMGS, among other green assessment tools.

Keywords: AES AGREE, AMGS, Central composite design, GAPI GC-MS, RP-HPLC. International Journal of Drug Delivery Technology (2024); DOI: 10.25258/ijddt.14.1.32

How to cite this article: Vineetha R, Krishnan M. An Ecologically Sound RP-HPLC Method for Estimating Citicoline using AQbD with Degradation Studies. International Journal of Drug Delivery Technology. 2024;14(1):216-223.

REFERENCES

  1. Secades JJ, Gareri P. Citicoline: pharmacological and clinical review, 2022 update. Rev Neurol. 2022; 30; 75(s05):S1-S89.
  2. De Maagd G, Philip Parkinson’s Disease and Its Management: Part 1: Disease Entity, Risk Factors, Pathophysiology, Clinical Presentation, and Diagnosis. P & T: a peer-reviewed journal for formulary management. 2015; 40(8):504-532.
  3. George DeMaagd, Ashok Philip, Parkinson’s disease and Its Management: Part 1: Disease Entity, Risk Factors, Pathophysiology, Clinical Presentation, and P & T: a peer-reviewed journal for formulary management. 2015; 40(8):504-510,532.
  4. Eberhardt R, Birbamer G, Gerstenbrand F, Rainer E, Traegner Citicoline in the treatment of Parkinson’s disease. Clin Ther. 1990; 12(6):489–95.
  5. Que DLS, Jamora RDG. Citicoline as Adjuvant Therapy in Parkinson’s disease: A Systematic Clinical Therapeutics. 2021; 43(1):19–31.
  6. Wisher Martindale the Complete Drug Reference. J Med LibrAssoc. 2012; 100(1):75–76.
  7. Jasielski P, Piędel F, Piwek M, Rocka A, Petit V, Rejdak K. Application of Citicoline in Neurological Disorders: A Systematic Nutrients. 2020; 12(10):3113.
  8. Ganduri RB, Peddareddigari JR, Dasari NR, Saiempu RK. Stability indicating LC method for the Determination of citicoline sodium in Injection formulation. Int J Pharm Tech Res. 2010; 2:427–33.
  9. Patil AS, Pethe A. Quality by Design (QbD): A new concept for development of quality pharmaceuticals. Int J Qual Assur. 2023; 1(4):13–9.
  10. Prajapati P, Shah H, Shah, Implementation of QRM and DoE- Based Quality by Design Approach to VEER Chromatography Method for Simultaneous Estimation of Multiple Combined Dosage Forms of Paracetamol. J. Pharm. Innov. 2022; 17:2–18.
  11. Monks K, Molnar I, Rieger HJ, Bogati B, Szabo E. Quality by Design: Multidimensional Exploration of the Design Space in High Performance Liquid Chromatography Method Development for Better Robustness Before J. Chromatogr. A 2012; 1232: 218–230.
  12. Sandhu PS, Beg S, Katare OP, Singh QbD-Driven Development and Validation of a HPLC Method for Estimation of Tamoxifen Citrate with Improved Performance. J. Chromatogr. Sci. 2016; 54: 1373–1384.
  13. Wasim Akram, Navneet Guard. Design expert as a statistical tool for optimization of 5-ASA-loaded biopolymer-based nanoparticles using Box Behnken factorial design. Future journal of pharmaceutical sciences. 2021; 7:146.
  14. Shailendra Bindaiya, Ameeta Argal. Development and validation of RP- HPLC method for determination of citicoline monosodium in pharmaceutical International Journal of Pharmaceutical Chemistry. 2012; 2(3):85-88.
  15. Sharma O, Chand T. Analytical Method Development and Its Validation for Estimation of Citicoline Sodium by Reversed Phase High Performance Liquid Chromatography (RP-HPLC). International Journal of Research in Pharmaceutical and Biomedical Sciences. 2013; 4:550–8.