Author(s):
J. Nageswara Rao, Ch. Sudhakar, Som Shankar Dubey
Email(s):
chsudhakargitam@gmail.com
DOI:
10.52711/0974-360X.2021.00668 
Address:
J. Nageswara Rao1, Ch. Sudhakar1*, Som Shankar Dubey2
1Department of Chemistry, Institute of Science, GITAM (Deemed to be University), Visakhapatnam - 530045, Andhra Pradesh, India.
2Department of Chemistry, Deen Dayal Upadhyay Gorakhpur University, Gorakhpur - 273009, Utter Pradesh, India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 7,
Year - 2021
ABSTRACT:
A new Isocractic RP-HPLC method was established for the assay of Tenofovir disoproxil orotate. As per ICH guidelines, the method was validated by using a chromatographic column YMC Pack ODS-AQ, (250mm x4.6mm x 5µm particle size,) at a temperature of 300C and an Isocractic mobile phase of 0.1% Triethylamine buffer, adjusted the pH to 6.0 with ortho phosphoric and acetonitrile in the ratio of (55%: 45%) was used with a flow rate of 1.0mLmin-1. The diluent is a mixture of water and acetonitrile in the ratio of (95:5v/v) and the sample cooler temperature was 5°C. The injection volume was 10µL and detection was achieved at 260nm with UV and PDA detector system for UV detection. The % RSD, Linearity, Range, Accuracy, Precision, Ruggedness (Intermediate Precision) and Robustness are found to be satisfactory. Therefore the method is assumed to be suitable for the assay of the Tenofovir disoproxil orotate by RP-HPLC method.
Cite this article:
J. Nageswara Rao, Ch. Sudhakar, Som Shankar Dubey. RP-HPLC Method Validation for the Assay of Tenofovir Disoproxil Orotate. Research Journal of Pharmacy and Technology. 2021; 14(7):3855-9. doi: 10.52711/0974-360X.2021.00668
Cite(Electronic):
J. Nageswara Rao, Ch. Sudhakar, Som Shankar Dubey. RP-HPLC Method Validation for the Assay of Tenofovir Disoproxil Orotate. Research Journal of Pharmacy and Technology. 2021; 14(7):3855-9. doi: 10.52711/0974-360X.2021.00668 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-7-65
REFERENCES:
1. Deeks SG et al. Safety, Pharmacokinetics and Antiretroviral Activity of Intravenous 9-[2-(R)-(Phosphonomethoxy) Propyl] Adenine, a Novel Anti-Human Immuno Deficiency Virus Therapy, in HIV injected Adults, Antimicrob. Agents Chemother., 1998; 42: 2380-2384.
2. Vere Hodge RA and Cheng YC, Antiviral Chem. Chemother., 1993; 4 (1): 13-24.
3. Kim YJ, Lee Y, Kang MJ, Huh JS, Yoon M, Lee J et al., RP-High Performance Liquid Chromatographic Determination of Tenofovir Disoproxil in Human Plasma for Bioequivalence Study, Biomed Chromatog., 2006; 20(11): 1172-1177.
4. Vela JE, Olson LY and Huang A. Development and Validation of a Sensitive LCMS/MS Method for the Determination of Tenofovir Disoproxil in Human Plasma, J. Pharm. Biomed. Anal., 2006; 27(5): 779-793.
5. Mondlol DK, Tyagi PK, Ravi VK, Dey S, Ashada RK, Mohanraj P; J Chem Pharm Res, 2009; 1(1): 286-296.
6. Kumdhavalli MV, Jayakar B, Kumar M, Saravanan C. J Chem Pharm Res, 2010; 2(1): 478-481.
7. K Anand Babu, B Jaykar. Int J Pharm Res Dev, 2011; 3(7), 9-14.
8. Anantha Kumar D, Srinivasa Rao G, Sheshagiri Rao J V L N. E-J Chem, 2009; 7(1): 180-184.
9. Savaser A, Goraler S, Tasoz A, Uslu B, Lingeman H, Ozkan S A. Chromatogr, 2007; 65(5-6): 259-265.
10. Sagar Suman Panda, Pratik Das, M.M. Annapurna. Int J Pharm Res Dev, 2009; 1(10): 1-9.
11. Malipatil SM, Nandedkar MA. J Ind Council Chem, 2009; 26(1): 67-69.
12. Kandagal PB, Manjunatha DH, Seetharamappa J, Kalanur SS. Anal Lett, 41, 4, 2008; 561-570
13. Rajesh Sharma, Pooja Gupta. Eurasian J Anal Chem, 2009; 4(3): 276-284.
14. N Appala Raju, Shabana Begum. Res J Pharm Tech, 2008; 1(4): 522-525.
15. Appala NR, Rao VJ, Vanitha PK, Mukilteo K, Srinivasu K. Orient J Chem, 2008: 24(2): 522-525
16. Mangoankar K, Desai A. Indian Drugs, 2008; 45(3): 188-192.
17. Pedro José Rolim-Neto. Brazilian J Pharm Sci, 2011; 47(1): 97-102
18. Montgomery ER, Edmanson AL, Cook SC, Hovsepian PK. J Pharm Biomed Anal, 2001; 25(2): 267-284.
19. Rao BU, Nikalje AP. Afr J Pharm Pharmacol, 2009; 3(12): 643-650,
20. Silverthorn C.F, Parsons T.L. Biomed Chromatogr, 2006; 20: 23-27.
21. Lopez R. M, Pou L, Gomez M. R, Ruiz I, Monterde J. J Chromatogr B. Biomed Sci Appl, 2001; 751: 371- 376.
22. Heeswijk RPG, Hoetelmans RMW, Meenhorst PL, Mulder JW, Beijnen JH. J Chromatogr B. Biomed Sci Appl, 1998; 713: 395-399.
23. Kaul N, Agrawal H, Paradkar AR, Mahadik KR. Talanta, 2004; 62: 843-852.
24. Li QC, Tougas T, Cohen K, Lee R, Meagan P, Corson M, Muchnick T. J Chromatogr Sci, 2000; 38: 246- 254.
25. Jahnavi V, A Ravi Kumar. Inventi Rapid: Pharm Analysis and Quality Assurance Vol. 2011
26. Joshi M, Nikalje AP, Shahed M, Dehghan M. Indian J Pharm Sci, 2009; 71(1): 95-97.
27. Laxman V. Potale, Amol S. Khodke, Shangiresh M. Patole, M.C Damle. J Adv Pharm Res, 2010; 1(2): 115- 122.
28. Hamrapurkar P, Phale M, Shah N. J Young Pharmacists, 2009; 4 (1): 359-363.
29. S. Anbazhagan, Narayanareddy, Indumathy, P. Shanmugapandiyan, Seshaiah Krishnan Sridhar. J Pharm Biomed Anal, 2005; 39(3-4): 801-804.
30. Shirkhedkar Atul A, Bhirud Charushila H, Surana Sanjay J. Pak J Pharm Sci, 2009; 22(1): 27-29.
31. Patel S, Baghel US, Rajesh P, Prabhakar D, Engla G, Nagar PN. Int J Pharm Cli Res, 2009; 1(1): 28-30.
32. International Conference on Harmonization, ICH Guidelines Q2 (R1), Validation of Analytical Procedures, Text and Methodology Ref. CPMP/ICH/381/95,