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


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