Force Degradation Study of Tenofovir Disoproxil Fumarate by UV-Spectrophotometric Method
Tenofovir disoproxil Fumarate (TDF), acyclic phosphonate nucleotide analogue, used as antiretroviral agents in the treatment of HIV-1 infection. A stability indicating UV -spectrophotometric method is simple, an accurate and economic, precise and reproducible method has been used for the estimation of Tenofovir disoproxil Fumarate in bulk and tablets dosage form in present work. The wavelength selected for the absorption correction method was 260 nm. The linearity range of 2-10μg/ml proved that it obeyed Beer’s Law and the correlation coefficient (r2) was found to be 0.999 at 260 nm. The drug was subjected to acid, alkali, peroxide, UV and Heat degradation. The force degradation studies of Tenofovir disoproxil Fumarate was done on Stress degradation by hydrolysis under alkaline condition by using 0.1N NAOH was found to be 10.6%. Stress degradation by hydrolysis under acidic condition by using 0.1N HCl and product degradation was found to be 10.95%. Oxidative degradation was done by using hydrogen peroxide and product degradation was found to be 12.22%. Neutral hydrolytic degradation was found to be 12.26%. Forced degradation studies of drug reveal good stability under the chosen experimental conditions.
2. ICH, Impurities in New Drug Products. International Conference on Harmonization, IFPMA, Geneva, 1996.
3. Budavari S, editor. The Merck Index. 13th ed. White House Station, NJ: Merck and Co. Inc; 200; 1628.
4. ICH, Q2A, Text on Validation of Analylical procedures, International Conference on Harmonization, Geneva,octomber 1994:1-5.
5. Christen, G.D.Analytical Chemistry 6th edition, John Wiley and Sons. 2003; 6:13l-l32
6. Kasture, A.V.; Mahadik, K.R.; Wadodkar, S.G. pharmaceutical Analysis Nirali Prakashan 1:5-7, 28-30.
7. Sharma B. Instrumental Method of analysis. 21st edition, Goel Publishing House. 2006: 6
8. Havele S., Dhaneshwar S. Stress Studies of Tenofovir Disoproxil Fumarate by HPTLC in Bulk Drug and Pharmaceutical Formulation. 2011: 6
9. Bhattacharyya S., Choudhury P. etb al. Estimation and Validation of Stability Indicating UV Spectrophotometric Method For The Determination Of Guaifenesin In Presence Of Its Degradant Products. 2013; 5:262-268.
10. Bojjagani R. Madasu S. Method Development and Validation of Forced Degradation Studies of Pioglitazone Hydrochloride by Using UV Spectroscopy.2012; 4:1750-1757.
11. Hossain F., Bhadra S. et al. The ICH guidance in practice: Stress degradation studies on aceclofenac and development of a validated stability-indicating reversed-phase HPLC assay in tablet dosage form.2013; 5:131-146.
12. Blessy M., PatelR.et al. Development of forced degradation and stability indicating studies of drugs. A review.2013; 5: 159–165.
13. Khagga B., Balaram V. et al. Development and Validation of Forced Degradation Studies of Atazanavir Using RP-HPLC and Characterization of Degradants by LC-MS/MS. 2015; 33(03):11-15.
14. S. Singh and M. Bakshi, “Guidance on conduct of stress tests to determine inherent stability of drugs,” Pharmaceutical Technology Online 2000; 24:1–143
15. S. Singh and M. Bakshi, “Development of validated stability indicating assay methods critical review,” Journal of Pharmaceutical and Biomedical Analysis, 2002; 28(6):1011–1040
16. Reynolds D., Facchine K. et al. Available guidance and best practices for conducting forced degradation studies, Pharm. Technol. 2002;26(3):48–56.
17. El-Saharty Y., Refaat M., et al. Stability- Indicating spectrophotometric and densitometric methods for determination of aceclofenac. Drug Dev. Ind. Pharm. vol. 28 No. 5, 2000; 28(5):571–582.
18. Grosa G, Grooso ED, Russo R, Allergrone G. Simultaneous, stability-indicating, HPLC-DAD determination of guaifenesin and methyl and propyl-parabens in cough syrup .J Pharm Biomed Anal.2006; 41:298-803.
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