Degradation Study Of Sofosbuvir In Bulk Drug And Tablet Dosage Form By RP-High Performance Liquid Chromatography
DOI:
https://doi.org/10.61841/3exf0358Keywords:
Sofosbuvir, RP-HPLC, Method Development, Method Validation, StabilityAbstract
Sofosbuvir were subjected to forced degradation conditions and the formed degradation products were well separated and resolved from the drug and excipients on SunFire C18 column (250 × 4.6 mm, 5 μ) using blend of Acetonitrile: Water (70: 30 v/v) pH 7.0 in isocratic mode at a flow rate of 0.8mL/min at an ambient temperature of 28 °C with the detection wavelength at 260nm. The retention time of Sofosbuvir was found 3.22 min. The linearity was performed in the concentration range of 20-100 ppm with correlation factor of 0.999 for Sofosbuvir. The percentage purity of Sofosbuvir tablet was found 99.98%. The drug was found to degrade under acid, alkali and oxidative condition but found stable under dry heat and photolytic conditions.
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References
1. https://pubchem.ncbi.nlm.nih.gov/compound/psi-7977#section=Drug-and-Medication-Information
2. Rani, J. S. and n. Devanna ,2017 A new RP-HPLC method development and validation for simultaneous estimation of Sofosbuvir and Velpatasvir in pharmaceutical dosage form. Int. J. Eng. Technol. Sci. Res 4: 145-152.
3. Nebsen, M. and E. S. Elzanfaly, 2016 Stability-indicating method and LC–MS-MS characterization of forced degradation products of Sofosbuvir. Journal of chromatographic science 54(9): 1631-1640.
4. Bandla, J. and S. Ganapaty, 2017 Stability indicating RP-HPLC method development and validation for the simultaneous determination of Sofosbuvir and Velpatasvir in tablet dosage forms”. Indian Journal of Pharmaceutical and Biological Research 5(04):10-16.
5. Annapurna, M. M., 2018 new stability indicating ultrafast liquid chromatographic method for the determination of Sofosbuvir in tablets. Asian Journal of Pharmaceutics (AJP): Free full text articles from Asian J Pharm 12(01).
6. Mastanamma, S., et al., 2017 Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of Sofosbuvir and Ledipasvir in bulk and their combined dosage form. Future Journal of Pharmaceutical Sciences 4(2): 116-123.
7. Sharma, M. and M. Murugesan 2018 Forced degradation study an essential approach to develop stability indicating method. Journal Chromatography Separation Techniques 8(1): 349.
8. Ahuja, S.S., 2007 Assuring quality of drugs by monitoring impurities. Advanced Drug Delivery Reviews, 59,3-11.
9. Alsante, K. M., et al., 2007 the role of degradant profiling in active pharmaceutical ingredients and drug products. Advanced drug delivery reviews 59(1): 29-37.
10. Alsante, K. M., et al. ,2003 A stress testing benchmarking study. Pharmaceutical technology 27(2): 60-73.
11. Bakshi, M. and S. Singh, 2002 Development of validated stability-indicating assay methods critical review. Journal of Pharmaceutical and Biomedical Analysis 28(6): 1011-1040.
12. Sushil D. Patil, Sunil V. Amrutkar and C. D. Upasani, 2019 A Stability Indicating RP-HPLC Method Development and Validation for the Determination of Combined Tablet Formulation of Amlodipine & Candesartan. IJSRR, 8(1), 2031-2044
13. Y. Haribabu, K. Nihila, VK. Sheeja, MB. Akhil, 2021. Method development and validation for simultaneous estimation of lamivudine, dolutegravir and tenofovir disoproxil fumarate in bulk and pharmaceutical dosage form using RP-HPLC and its application to in-vitro dissolution study. Jour. of Med. P’ceutical & Allied. Sci. V 10 - I 4, 1165 P- 3202-3207
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