Stability indicating high performance liquid chromatography (HPLC) method was developed for the assay of Tenofovir in bulk and solid dose formulation. The HPLC separation was achieved on kromasil C18 (100mm × 4.6mm, 5 µm) column using a mobile phase of Methanol: Potassium dihydrogen orthophosphate buffer (30:70,v/v) at a flow rate of 1 ml min-1 and UV detection at 260 nm. Peak elutes at 7.33 appropriate. The method was validated for linearity, repeatability, accuracy, precision, robustness, limit of detection and limit of quantification. The accuracy was between 99.14 - 99.97%. The highest R.S.D. amongst interday and Intraday precision was found 0.808 and 0.473 respectively.The assay was linear over the concentration range of 10-50 µg/ml (R˜0. 999). The method was robust as no significant change in chromatographic parameters. LOD and LOQ was found to be 0.90 and 2.71 respectively. The stress studies were performed per ICH guidelines to confirm its Stress testing was carried out in presence of acid, base, hydrogen peroxide, heat and light to demonstrate speci?city of the method as per ICH guidelines. The developed method could separate the potential degradation products from the Tenofovir peak. It was concluded that highest degradation occurs in basic condition. This proposed method was suitable and practical for analysis the content of Tenofovir in pharmaceutical products and could be of bene?t for the prediction shelf life of Tenofovir in marketed formulations.
Cite this article:
Gurmeet S. Chhabra, Aayushi Rajora, Dinesh K. Mishra. Stability indicating RP-HPLC method for the determination of Tenofovir in pharmaceutical formulation. Research Journal of Pharmacy and Technology. 2021; 14(12):6335-9. doi: 10.52711/0974-360X.2021.01095
Gurmeet S. Chhabra, Aayushi Rajora, Dinesh K. Mishra. Stability indicating RP-HPLC method for the determination of Tenofovir in pharmaceutical formulation. Research Journal of Pharmacy and Technology. 2021; 14(12):6335-9. doi: 10.52711/0974-360X.2021.01095 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-12-25
1. https://www.drugbank.ca/ (accessed on 10th March 20)
2. Ettre, LS. Nomenclature for chromatography (IUPAC Recommendations 1993) Pure Appl Chem.1993; 65(8): 19-872.
3. Manasi, A.; Rohit, C. A. Rapid Stability Indicating RP-HPLC Method and the Degradation Kinetics Data for the Simultaneous Estimation ofTenofovir disoproxil fumarate and Emtricitabine, International Journal of Pharmacy and Pharmaceutical Research. 2015; 3:145-59.
4. Abdelhay, M.H.;Gazy, A.A.; ShaalanRA.;Ashour HK. Selective RP-HPLC DAD Method for Determination of Tenofovir fumarate and Emtricitabine in BulkPowder and in Tablets. Acta Chromatographica. 2015; 27: 41–54.
5. Akbar, B.; Sireesha, D.; D, Rajini T, Akifulhaque, M; Harshini, S.; Method development and validation for simultaneous estimation of Tenofovirdisoproxil fumarate and Emtricitabine in pharmaceutical dosage form by RP-HPLC method. International Journal of Innovative Pharmaceutical Sciences andResearch. 2015; 3: 1537-1545.
6. Bala, R R; Mutta Reddy, Y S; B, Sekhara. Simultaneous Estimation of Emtricitabine and Tenofovir disoproxil fumarate in tablet dosage form byReverse Phase High-performance Liquid Chromatography. Chromatographic Science ; 2015: 1, 1-6.
7. Vanitha, C.;Pradeep Kumar, P.;Swarnalatha, G.; Sekar, V. Simultaneous Estimation of Emtricitabine and Tenofovir disoproxil fumarate in atablet dosage form by RP-HPLC Method. International Journal of Pharmaceutical Development & Technology. 2014; 4: 279-283.
8. Sumanth A.; Venkateswa Rao P. Analytical Method development and validation of simultaneous estimation of Tenofovir and Emtricitabinein bulk and Pharmaceutical dosage forms By Using RP-HPLC. Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 2013; 1: 60-69.
9. Sreenivasa, R B; Nagaraju, S; Kiran, BV. Development, Validation and Stress Degradation Studies of Emtricitabine and Tenofovir disoproxil fumarate by High Performance Liquid Chromatography. Asian Journal of Research in Chemistry. 2013; 6: 936.
10. Viswanath V.;Shanmuga Sundaram. P; Ravichandiran. RP-HPLC Method for the Simultaneous Estimation of Tenofovir disoproxil fumarate and Emtricitabine in Combined tablet dosage form. International Journal of Pharm Tech Research. 2013, 5, 1186-1195.
11. Badgujar, BP.; Mahajan, MP.; Sawant, SD. Development and validation ofRP-HPLC method for the simultaneous estimation of tenofovir alafenamide andemtricitabine in bulk and tablet dosage form. Intl J of Chem Tech Res. 2017; 10: 731739.
12. Akram, NMD.; Umamahesh, MA. New validated RP-HPLC method for thedetermination of emtricitabine and tenofovir af in its bulk and pharmaceuticaldosage forms. J Chem Pharm Science2017; 10: 54-59.
13. Gandla, KS.; Rajkumar, M.; Pranay, K.; Sudheer, KD.New stability indicating RP-HPLC method for the simultaneous estimation of tenofovir alafenamide andemtricitabine in bulk and combined tablet dosage forms. Asian J Pharm Anal Med Chem 2017; 5: 142-149.
14. RM Jeswani, PK Sinha, KS Topagi, MC Damle. A Validated Stability Indicating HPTLC Method for Determination of Pentoxifylline in Bulk and Pharmaceutical Formulation. Research J. Pharm. and Tech.2 (3): July-Sept. 2009,Page 527-530.
15. Shailaja K., Revathi R., Saravanan V. S. Stability indicating RP-HPLC method for the estimation of Emtricitabine and Tenofovir disoproxil fumerate in tablet dosage form. Research J. Pharm. and Tech. 6(1): Jan. 2013; Page 80-85.
16. Rajan V. Rele, Sandip P. Patil. Application of RP-HPLC Technique for development of Analytical method for Validation of Tenofovir disoproxil fumarate from Bulk drug and Dosage form. Research J. Pharm. and Tech. 2019; 12(10):4752-4756
17. International Conference on Harmonization (ICH) Guidelines. Q1A (R2), ICH Guidelines: Stability Testing of New Drug Substances and Products, Geneva, 2003.
18. ICH validation of analytical procedures: text and methodology Q2 (R1), International Conference on Harmonization, 2005.
19. ICH stability testing of new drug substances and products Q1A (R2), International Conference on Harmonization, 2003.
20. ICH Q2 (R1) Validation of Analytical Procedures. Text and Methodology, International Conference on Harmonization; 2005