Author(s):
Venna R Surya Anusha, Koppala RVS Chaitanya, Rajeswari Aleti, Kolapalli Venkata Ramana Murthy
Email(s):
rajeswarianusha@gmail.com
DOI:
10.52711/0974-360X.2023.00844
Address:
Venna R Surya Anusha1*, Koppala RVS Chaitanya2, Rajeswari Aleti1, Kolapalli Venkata Ramana Murthy1
1AU College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India, 530003.
2Department of Pharmacology, Vignan Institute of Pharmaceutical Technology, Kapujaggrajupeta, Duvvada, Visakhapatnam, India, 530049.
*Corresponding Author
Published In:
Volume - 16,
Issue - 11,
Year - 2023
ABSTRACT:
A simple, reliable and sensitive RP-HPLC bioanalytical method with PDA as detector was developed for the estimation of donepezil HCl in the rabbit plasma and validated. The biological samples were extracted and analysed using loratadine as internal standard. The sample analysed with Inertsil ODS 150mm x 4.6mm, 5.0µm particle size column using 70:30 v/v of 0.1% trifluoroacetic acid and acetonitrile mobile phase at flow rate of 1mL/min. All the parameters validated were within the limits proposed in bioanalytical method validation guidelines. The linearity was observed in the range of 5-200ng/mL with LOD of 0.9ng/mL. The method was observed to have short analysis time of 6 min and also found to be successful in studying the pharmacokinetic parameters of donepezil HCl.
Cite this article:
Venna R Surya Anusha, Koppala RVS Chaitanya, Rajeswari Aleti, Kolapalli Venkata Ramana Murthy. Bio-analytical Method for the Pre-clinical Estimation of Donepezil Hydrochloride in Rabbit Plasma by RP-HPLC. Research Journal of Pharmacy and Technology. 2023; 16(11):5207-2. doi: 10.52711/0974-360X.2023.00844
Cite(Electronic):
Venna R Surya Anusha, Koppala RVS Chaitanya, Rajeswari Aleti, Kolapalli Venkata Ramana Murthy. Bio-analytical Method for the Pre-clinical Estimation of Donepezil Hydrochloride in Rabbit Plasma by RP-HPLC. Research Journal of Pharmacy and Technology. 2023; 16(11):5207-2. doi: 10.52711/0974-360X.2023.00844 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2023-16-11-38
REFERENCES:
1. Indian Pharmacopeia 2007, Volume -2. The Indian Pharmacopoeia Commission, Ghaziabad, Government of India, Ministry of Health and Welfare; 2007.
2. US Pharmacopeia and National Formulary. United States Pharmacopeial Convention, Inc.; 2006. Available at: https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/donepezilhydrochloride.pdf.
3. Rogers SL and Friedhoff LT. The efficacy and safety of donepezil in patients with Alzheimer’s disease: results of a US multicentre, randomized, double-blind, placebo-controlled trial. The Donepezil Study Group. Dementia, 1996; 7: 293-303.
4. Burt T. Donepezil and related cholinesterase inhibitors as mood and behavioral controlling agents. Current psychiatry reports. 2000; 2: 473-478.
5. US Pharmacopeia and National Formulary. United States Pharmacopeial Convention, Inc.; 2006. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020690Orig1s000rev.pdf.
6. United States Food and Drug Administration. Aricept prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020690s035,021720s008,022568s005lbl.pdf.
7. Yasui-Furukori N, Furuya R, Takahata T, Tateishi T. Determination of donepezil, an acetylcholinesterase inhibitor, in human plasma by high-performance liquid chromatography with ultraviolet absorbance detection. Journal of Chromatography B. 2002; 768(2): 261-265.
8. Bhateria M, Ramakrishna R, Pakala DB, Bhatta RS. Development of an LC–MS/MS method for simultaneous determination of memantine and donepezil in rat plasma and its application to pharmacokinetic study. Journal of Chromatography B. 2015; 1001: 131-139.
9. Noetzli M, Ansermot N, Dobrinas M, Eap CB. Simultaneous determination of antidementia drugs in human plasma: Procedure transfer from HPLC–MS to UPLC–MS/MS. Journal of Pharmaceutical and Biomedical Analysis. 2012; 64:16-25.
10. Mohamed FA, Khashaba PY, Shahin RY, El-Wekil MM. Determination of donepezil in spiked rabbit plasma by high-performance liquid chromatography with fluorescence detection. Royal Society Open Science. 2019;6(1):181476.
11. Krishna KV, Saha RN, Singhvi G, Dubey SK. Pre-clinical pharmacokinetic-pharmacodynamic modelling and biodistribution studies of donepezil hydrochloride by a validated HPLC method. RSC Advances. 2018;8(44):24740-24749.
12. Bagyalakshmi J, VijayarajS, Sindhu, Ravi TK. Method Development and Validation of Erythrosine (E127) Using RP-HPLC Coupled With PDA Detector. Asian J. Research Chem. 2008; 1(2): 95-96.
13. TentuNageswara Rao, Muralidhar Reddy Avuthu, Venkata Reddy B, Murthy SNVS. Forced degradation study of Terbinafine HCl by HPLC with PDA detector. Asian J. Research Chem. 2016; 9(11): 561-565.
14. TentuNageswara Rao, Vijayalakshmi A, Karri Apparao, Krishnarao N. A New Analytical Method Validation and Quantification of OlmesartanMedoxomil and its related impurities in bulk drug product by HPLC. Asian J. Pharm. Tech. 2017; 7(3): 147-152.
15. Satya Raga Devi A, Ashutosh Kumar S, Saravanan J, ManidipaDebnath, Greeshma V, Sai Krishna N, Naga Madhusudhan Rao Ch. A New RP-HPLC Method Development for Simultaneous Estimation of Metformin and Gliclazide in Bulk as well as in Pharmaceutical Formulation by using PDA Detector. Research J. Pharm. and Tech. 2014; 7(2): 142-150.
16. Ashutosh Kumar S, ManidipaDebnath, Seshagiri Rao J.V.L.N., GowriSankar D. Development and Validation of a Sensitive RP-HPLC method for Simultaneous Estimation of Rosuvastatin and Fenofibrate in Tablet Dosage form by using PDA Detector in Gradient Mode. Research J. Pharm. and Tech. 2016; 9(5): 549-554.
17. MeruguManasa, VijeyAanandhi M. Stability Indicating Method Development and Validation of Semaglutide by RP-HPLC in Pharmaceutical substance and Pharmaceutical Product. Research J. Pharm. and Tech 2021;14(3):1385-1389
18. Prashanthi Y, TentuNageswara Rao, Yellapu Srinivas. Method Development and Validation of Alectinib Drug by RP-HPLC in Bulk and Pharmaceutical Dosage Form. Asian J. Pharm. Ana. 2018; 8(4): 186-190.
19. Balaswami B, Ramana PV, Rao BS, Sanjeeva P. A New Simple Stability-Indicating RP-HPLC-PDA Method for Simultaneous Estimation of Triplicate Mixture of Sofosbuvir, Velpatasvir and Voxilaprevir in Tablet Dosage Form. Research Journal of Pharmacy and Technology. 2018;11(9):4147-56.
20. US Pharmacopeia and National Formulary. (USP31-NF26) <621>Chromatography. United States Pharmacopeial Convention, Inc. 2006; 29(5): 152.
21. Amruta S. Kadam, Nayana V. Pimpodkar, Puja S.Gaikwad, Sushila D. Chavan. Bioanalytical Method Validation. Asian J. Pharm. Ana. 2015; 5(4): 219-225.
22. R. B. Saudagar, P. G. Thete. Bioanalytical Method Validation: A Concise Review. Asian J. Res. Pharm. Sci. 2018; 8(2):107-114. Advaita B. Patel. Analytical Method Validation: Collation between International uidelines. Asian J. Research Chem. 2017; 10(6): 857-866.
23. Chung M. Computation of model-independent pharmacokinetic parameters during multiple dosing. Journal of Pharmaceutical Science, 1984; 73: 570-571.
24. Yamaoka K, Nakagawa T and Uno T. Statistical moments in pharmacokinetics. Journal of Pharmacokinetics and Biopharmaceutics 1978; 6: 547-558.