Author(s):
B. Srivastava, Sheeja V.K, Y. Haribabu, Ebin C.J
Email(s):
sheejasureshsree@yahoo.com
DOI:
10.52711/0974-360X.2021.00439 
Address:
B. Srivastava, Sheeja V.K*, Dr. Y. Haribabu, Ebin C.J
Department of Pharmaceutical Analysis, Grace College of Pharmacy, Palakkad, Kerala, 678004, India.
*Corresponding Author
Published In:
Volume - 14,
Issue - 5,
Year - 2021
ABSTRACT:
A selective, sensitive, rugged and high throughput high performance liquid chromatography tandem mass spectrometric method was developed for the simultaneous estimation of Emtricitabine and Tenofovir Alafenamide in Bulk and Tablet Dosage form. Liquid chromatography system has been coupled with tandem quadrupole mass spectroscopy with LC-20AD pump, electrospray ionization (ESI) interface, PDA detector (SPD-M20), column oven (CTO-20AC), CEM-20 alite controller and SIL-20AC auto sampler. Lab solution data station software was used. The separation of both Tenofovir and Emtricitabine was achieved by Gemini C18 column (4.6×100mm, 5µm) as a stationary phase with 0.1 % formic acid: methanol at the ratio of 20:80, v/v at a flow rate of 0.5ml/min and injection volume of 10 µl. The percentage Recovery of the Drug Tenofovir Alafenamide and Emtricitabine was 96.59 and 96.84% respectively. The linearity range was 20-120 ng/ml for both the drugs and the LOD was found to be 5 and 10 ng/ml and LOQ were 15 and 20 ng/ml for Tenofovir and Emtricitabine Respectively. The developed method was precise, accurate, sensitive and can be used for the routine quality control of the drug formulation.
Cite this article:
B. Srivastava, Sheeja V.K, Y. Haribabu, Ebin C.J. Method Development and Validation of Simultaneous Estimation of Emtricitabine and Tenofovir Alafenamide in Bulk and tablet Dosage form using LC-MS/MS. Research Journal of Pharmacy and Technology. 2021; 14(5):2493-6. doi: 10.52711/0974-360X.2021.00439
Cite(Electronic):
B. Srivastava, Sheeja V.K, Y. Haribabu, Ebin C.J. Method Development and Validation of Simultaneous Estimation of Emtricitabine and Tenofovir Alafenamide in Bulk and tablet Dosage form using LC-MS/MS. Research Journal of Pharmacy and Technology. 2021; 14(5):2493-6. doi: 10.52711/0974-360X.2021.00439 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-5-23
REFERENCE:
1. Stephen Weller, Julie Borland, Shuguang Chen, Mark Johnson, Paul Savina, Brian Wynne, Toshihiro Wajima, Amanda F. Peppercorn, Stephen C. Piscitelli. European Journal of Clinical Pharmacology, 2014, 70; 29–35.
2. Guidance for Industry, Bioanalytical Method Validation, U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research, 2001.
3. Bennetto-Hood C, Tabolt G, Savina P, Acosta EP. J Chromatogr B Analyt Technol Biomed Life Sci. 2014 Jan 15;945-946: 225-32.
4. J. X. de Vries, A. Voss. Biomedical Chromatography, 1993, 7(1), 12-14
5. Taomin Huang, Zhong He, Bei Yang, Luping Shao, Xiaowei Zheng, Gengli Duan. Journal of Pharmaceutical and Biomedical Analysis, 2006, 41(2), 644-648.
6. Nevin Erk. Journal of Chromatography B, 2003, 784(1), 195-201.
7. Fei Liu, Yu Xu, Shu Gao, Jundong zhangb, Qingxiang Guo , Journal of Pharmaceutical and Biomedical Analysis, 2007, 44(5), 1187-1191.
8. Dragica Zendelovska, Trajče Stafilov, and Petar Miloševski. Biomedical Chromatography, 2004, 18(2), 71-76.
9. Connie T. Azumaya. Journal of Chromatography B: Biomedical Sciences and Applications, 1990, 532, 168-174.
10. N. V. S. Ramakrishna, K. N. Vishwottam, S. Manoj, M. Koteshwara, S. Wishu and D. P. Varma. Biomedical Chromatography, 2005, 19(10), 751–760.
11. Hao Li, Yingwu Wang, Yao Jiang, Yunbiao Tang, Jiang Wang, Limei Zhao, Jingkai Gu. Journal of Chromatography B, 2007, 852(1-2), 436-442.
12. Dongyang Liu, Ji Jiang, Peng Wang, Sheng Feng, Pei Hu, . Journal of Chromatography B, 2010, 878(9-10), 743-748.
13. Sagar A. Parekh, Ashutosh Pudage, Santosh S. Joshi, Vikas V. Vaidya, Noel A. Gomes, Sudhir S. Kamat Journal of Chromatography B, 2008, 873(1), 59-69.
14. Maha F. Tutunji , Husam M. Ibrahim, Manal H. Khabbas, Lara F. Tutunji . Journal of Chromatography B, 2009, 877(16-17), 1689-1697.
15. Leena R. Bhata, Rahul K. Godgea, Asfak T. Voraa and Mrinalini C. Damlea. Journal of Liquid Chromatography and Related Technologies, 2007, 30(20), 3059-3067.
16. Ritesh Sharma, Shyam Pancholi. Acta Pharmaceutica, 2012, 62( 1), 45-58.
17. Samya M. El-Gizawy, Osama H. Abdelmageed, Mahmoud A. Omar, Sayed M. Deryea, Ahmed M. AbdelMegied. American Journal of Analytical Chemistry, 2012, 3(6), 422-430.
18. D Vijaya Bharathi, Kishore Kumar Hotha, Pankaj K Chatki, Satyanarayana V, Venkateswarlu V. Bioanalysis, 4(10), 1195-1204.