Author(s):
C. Parthiban, Vislavath Anjali, Vollala Supriya, Dhontam Bhanu Priya, Sadineni Sri Nithya, M. Sudhakar
Email(s):
parthi1617@gmail.com
DOI:
10.52711/2231-5713.2023.00043 
Address:
C. Parthiban*, Vislavath Anjali, Vollala Supriya, Dhontam Bhanu Priya, Sadineni Sri Nithya, M. Sudhakar
1Professor, Malla Reddy College of Pharmacy, Maisammaguda, Dhulapally, Secunderabad - 500100. Telangana, India.
2Department of Pharmaceutical Analysis, alla Reddy College of Pharmacy, Secunderabad - 500100, Telangana, India.
*Corresponding Author
Published In:
Volume - 13,
Issue - 4,
Year - 2023
ABSTRACT:
A simple, precise and accurate method was developed for the simultaneous estimation of memantine and donepezil. The chromatogram was performed with a Thermo scientific C18 (150 x 4.6mm, 5µm). At a flow rate of 1ml/min, mobile phase used is 70:30% v/v mixture of buffer pH 4.5 and ACN. The best detection wave length for memantine and donepezil was at 265nm. The retention time was 2.325 and 3.088minutes. Assay results of 100.87 percent and 99.31 percent, %RSD values are below 2 and linearity R2 values are 0.999 for both the drugs. The strategy appears to have been compact and worth, and it is proper for everyday Quality Control Estimates in Industry sections since Maintenance Times are Diminishing and that Gathered Code was reducing. Thus, the developed method was validated according to 1CH guidelines for routine analysis of the sample.
Cite this article:
C. Parthiban, Vislavath Anjali, Vollala Supriya, Dhontam Bhanu Priya, Sadineni Sri Nithya, M. Sudhakar. Analytical Method Development and Validation for Simultaneous Estimation of Memantine and Donepezil in Pharmaceutical Dosage form by RP-HPLC. Asian Journal of Pharmacy and Technology. 2023; 13(4):243-6. doi: 10.52711/2231-5713.2023.00043
Cite(Electronic):
C. Parthiban, Vislavath Anjali, Vollala Supriya, Dhontam Bhanu Priya, Sadineni Sri Nithya, M. Sudhakar. Analytical Method Development and Validation for Simultaneous Estimation of Memantine and Donepezil in Pharmaceutical Dosage form by RP-HPLC. Asian Journal of Pharmacy and Technology. 2023; 13(4):243-6. doi: 10.52711/2231-5713.2023.00043 Available on: https://ajptonline.com/AbstractView.aspx?PID=2023-13-4-1
REFERENCES:
1. Kilpatrick GJ, Tilbrook GS. Memantine. Merz. Current Opinion In Investigational Drugs. 2002; 3(5):798-806.
2. Mobius HJ, Stoffler A, Graham SM. Memantine Hydrochloride: Pharmacological and Clinical Profile. Drugs of Today. 2004; 40(8):685-96.
3. Moretti R, Torre P, Antonello RM, Cattaruzza T, Pizzolato G. Memantine: It’s Role In Vascular Dementia. Drug Design Reviews-Online. 2005; 2(6):449-56.
4. Narola B, Singh AS, Santhakumar PR, Chandrashekhar TG. A Validated Stability-Indicating Reverse Phase HPLC Assay Method For The Determination Of Memantine Hydrochloride Drug Substance With UV-Detection Using Precolumn Derivatization Technique. Analytical Chemistry Insights. 2010; 5: ACI-S3936.
5. Michail K, Daabees H, Beltagy Y, Abdel-Khalek M, Khamis M. Spectrophotometric and Spectrofluorimetric Determination Of Memantine Hydrochloride In Bulk And Pharmaceutical Preparations. International Journal of Pharmacy and Pharmaceutical Sciences. 2011; 3(3):180-5.
6. Bonin-Guillaume S, Zekry D, Giacobini E, Gold G, Michel JP. The Economical Impact of Dementia. Presse Médicale (In French). 2015; 34 (1): 35–41. Doi:10.1016/S0755-4982(05)83882-5. PMID 15685097.
7. Meek PD, Mckeithan K, Schumock GT. Economic Considerations In Alzheimer's Disease. Pharmacotherapy. 1998; 18 (2 Pt 2): 68–73, Discussion 79–82. Doi:10.1002/J.1875- 9114.1998.Tb0
8. Alzheimer's Disease: Symptoms. National Institute On Aging. Archived From The Original On 15 January 2012. Retrieved 28 December 2011.
9. Allen, DW; Cooksey, C; Tsai, BK (Nov 13, 2009). Spectrophotometry. NIST. Retrieved Dec 23, 2018.
10. Gerber, Frederic. Practical Aspects Of Fast Reversed-Phase High-Performance Liquid Chromatography Using 3 Μm Particle Packed Columns And Monolithic Columns In Pharmaceutical Development And Production Working Under Current Good Manufacturing Practice. Journal Of Chromatography. 2004; 1036 (2): 127–33. Doi:10.1016/J.Chroma.2004.02.056. PMID 15146913.
11. ICH validation of Analytical procedures: Text and Methodology Q2 (R1) in proceedings of International Conference on Harmonization. Geneva: Switzerland. 2005; 205-210.
12. ICH guidelines. Validation of Analytical procedures technical requirements for registration of Pharmaceuticals for Human use Text and Methodology Q2 (R1). International Conference on Harmonization. Geneva: Switzerland. 2005; 325-340.
13. J. Nagamallika, Aruna Mahesh. Development and Validation of Spectrophotometric Method for the Estimation of Aripiprazole in Tablet Dosage Form. Asian Journal of Pharmaceutical Analysis. 2011; 1(3): 46-49.
14. Priyanka. R. Varade, Mahavir G. Narwade, Varsha N. Tambe. Method development and validation of Irbesartan by RP-HPLC Method. Research Journal of Science and Technology. 2020; 12(2): 131-135.
15. Akash Shelke, Someshwar Mankar, Mahesh Kolhe. Development and Validation of RP-HPLC Method for estimation of Secnidazole in API and Pharmaceutical Dosage Form. Research Journal of Science and Technology. 2021; 13(2): 100-104.
16. Kapil Rana, Pushpendra Sharma. Analytical Method Development and Validation for the Simultaneous Estimation of Metformin Hydrochloride and Alogliptin by RP-HPLC in Bulk and Tablet Dosage Forms. Research Journal of Science and Technology. 2021; 13 (2): 111-118.
17. Vishakha Shingote, S. D. Mankar, S. B. Dighe. A Review Article on Analytical Methods Development and Validation, Research Journal of Science and Technology. 2022; 14(1): 77-83.
18. Dipak Nalawade, R. K. Godge, S. D. Magar. Analytical Method Development and Validation of Ritonavir. Research Journal of Science and Technology. 2020; 12(2): 157-162.
19. Santoshkumar R. Mulik, Rishikesh S. Bachhav, Bulk Solution Assay Test Procedure Development and validation for Esomeprazole Sodium Injection 40mg as a CPP. Research Journal of Science and Technology. 2021; 13(3): 177-182.
20. M. K. Ranganath, Prasanta Deka, Kalyani Arikatla. Simultaneous method development and Validation of Amlodipine and Valsartan by HPLC. Research Journal of Science and Technology. 2020; 12(3): 183-189.
21. Yogita Dighe, R. B. Laware, S. B. Dighe. Analytical Method Development and Validation of Linezolidine – A Review. Research Journal of Science and Technology. 2020; 12(1): 13-22.
22. P.N. Agrawal and Namrata E. Teli. A Validated and Simplified RP-HPLC Method for Estimation of Ebastine from Bulk Drugs. Asian Journal of Research in Chemistry. 2011; 4(7): 1164=1167.