ABSTRACT:
The objective of the study was to develop a simple, accurate, precise and rapid a UV spectrophotometric method, area under curve method for the determination of emtricitabine and tenofovir disoproxil fumarate in combined dosage form. The method was further validated by ICH guidelines. The proposed area under curve method involves the measurement of area at selected analytical wavelength ranges and performing the analysis using “Cramer’s rule and Matrix method”. The two analytical wavelengths ranges were used i.e. 255-265nm and 272- 286nm for estimation of emtricitabine and tenofovir disoproxil fumarate respectively. The linearity of the proposed method was found in the concentration range of 2 – 20µg/ml (r2= 0.9999) for emtricitabine and tenofovir disoproxil fumarate respectively. The percentage mean recovery was found to be 100.129% emtricitabine and 100.30% for tenofovir disoproxil fumarate respectively. The method was statistically validated for its linearity, accuracy and precision as per ICH guidelines. Both intra and inter day variation showed less percentage (%) RSD values indicating high grade of precision of this method.
Cite this article:
Rajan V. Rele. Simultaneous Spectrophotometric Estimation of Emtricitabine and Tenofovir disoproxil fumarate by Area Under Curve Method in Combined Dosage Form. Asian J. Research Chem. 2021; 14(1):67-72. doi: 10.5958/0974-4150.2021.00011.0
Cite(Electronic):
Rajan V. Rele. Simultaneous Spectrophotometric Estimation of Emtricitabine and Tenofovir disoproxil fumarate by Area Under Curve Method in Combined Dosage Form. Asian J. Research Chem. 2021; 14(1):67-72. doi: 10.5958/0974-4150.2021.00011.0 Available on: https://ajrconline.org/AbstractView.aspx?PID=2021-14-1-11
REFERENCES:
1. Rele R.V. UV Spectrophotometric Estimation of Emtricitabine by Zero order and area under Curve methods in Bulk and Pharmaceutical Dosage Form. Asian journal of chemistry. 12(5; 2019):263-267.
2. Rajan V. Rele Prathamesh P. Tiwatane. Derivative UV Spectrophotometric Method for validation of Emtricitabine in Bulk and Pharmaceutical Dosage Form. Asian journal of chemistry. 13(1); 2020):48-51.
3. Rajan V. Rele Prathamesh P. Tiwatane UV Spectrophotometric Estimation of Tenofovir disoproxil fumarate by Area under Curve Methods in Bulk and Pharmaceutical Dosage Form. . Asian journal of chemistry 13(1); 2020):7-11
4. Dinesh Dhatkar, Sufiyan Ahmad, V. M. Shastry, Development and Validation of UV-Visible Spectrophotometric Method for Estimation of Tenofovir disoproxil fumarate and Tenofovir in Bulk and Dosage Form. International journal of pharmacy and pharmaceutical research. 9 (3); 2017: 74-84
5. Budagam Lavanya et.al. Method development and validation of combined dosage form of Tenofovir disoproxil fumarate and Tenofovir disproxil fumarate by ultra violet spectroscopy. International research journal of pharmacy.3(12);2012:104-108.
6. Anindita Behera, Aurobinda Parida1, Amit Kumar Meher, Dannana Gowri Sankar, Swapan Kumar Moitra1, Sudam Chandra Si. Development and Validation of Spectrophotometric method for determination of Tenofovir disoproxil fumarate and Tenofovir disoproxil Fumarate in Bulk and Tablet dosage form, International Journal of PharmTech Research, 3(3);2011:1874-1882.
7. Mohammad H. AbdelHay, Azza A. Gazy, Rasha A. Shaalan, and Heba K. Ashour, Simple Spectrophotometric Methods for Determination of Tenofovir Fumarate and Tenofovir disoproxil fumarate in Bulk Powder and in Tablets, Journal of spectroscopy, 2013, Article ID 937409, 7 pages, http://dx.doi.org/10.1155/2013/ 937409.
8. K. Vanitha Prakash, M. Padmalatha and Eranna Dopadally, Extractive spectrophotometric determination of tenofovir, Biosciences, Biotechnology Research Asia, 7(1);2010: 445-448.
9. Dr. A.J. Pratapareddy, I.E. Chakravarthi, New Spectrophotometric Determination of Tenofovir Disoproxil Fumaratein Bulk and Pharmaceutical Dosage Form, Journal of Applied Chemistry, 1( 2);2012: 29-33.
10. Rajan V. Rele, sandip P. Patil. Development of Analytical Method by RP-HPLC Method for Validation of Emtricitabine in API and Pharmaceutical Dosage Form. Asian J. Research Chem. 12(3); 2019:143-147.
11. Bhushan P. Badgujar, Moreshwar P. Mahajan, Sanjay D. Sawant. Development and validation of RP-HPLC method for the simultaneous estimation of tenofovir alafenamide and tenofovir disoproxil fumarate in bulk and tablet dosage form, International Journal of ChemTech Research, 10 (5);2017: 731-739.
12. 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. 12(10); 2019:4752-4756.
13. Arun Ramaswamy A, Anton Smith Arul Gnana Dhas. Development and validation of analytical method for quantitation of tenofovir disoproxil fumarate, tenofovir, efavirenz based on HPLC. Arabian Journal of Chemistry 11:2018: 275–281.
14. Ajay D. Mali and Uttam B. More. RP-HPLC method for simultaneous estimation of impurities from tenofovir disoproxil fumarate and tenofovir disoproxil fumarate tablet, International Journal of Pharmaceutical Sciences and Research, 7(4);2016: 1662-1669.
15. Mallikarjuna rao Nagasarapu1 and Gowri Sankar Dannana. Development and validation of stability-indicating hplc-dad method for simultaneous determination of tenofovir disoproxil fumarate, elvetegravir, cobicistat and tenofovir in their tablet dosage forms, Indian Journal of Pharmaceutical Education and Research, 50 ( 1);2016: ,205-211.
16. Kalpana Jayapalu, Himaja Malipeddi, Anbarasu Chinnasamy, Chromatographic separation and in vitro dissolution assessment of tenofovir disoproxil fumarate, tenofovir disoproxil fumarate and nevirapine in a fixed dose combination of antiretrovirals, Journal of applied pharmaceutical science, 4 (11);2014: 076-080.
17. PSRCHNP Varma D and A Lakshmana Rao., Stability-Indicating RP-hplc method for the simultaneous estimation of efavirenz, tenofovir and tenofovir disoproxil fumarate in pharmaceutical formulations., Indian Journal of Pharmacy and Pharmacology, 1(1); 2014:, 1-17.
18. Bala Rami Reddy.Yenumula1, Mutta Reddy.Singampalli and Bala Sekhara Reddy.Challa, Simultaneous estimation of tenofovir disoproxil fumarate and tenofovir disoproxil fumarate in tablet dosage form by reverse phase high-performance liquid chromatography, International Journal of Analytical Techniques, SOJ Chromatograph Sci 1(1); 2015:6.2-6.
19. Prashant S. Devrukhakar, Roshan Borkar, Nalini Shastri, and K. V. Surendranath, A Validated stability-indicating RP-HPLC method for the simultaneous determination of tenofovir, tenofovir disoproxil fumarate, and a efavirenz and statistical approach to determine the effect of variables, ISRN Chromatography, 2013, Article ID 878295, 8 pages, http://dx.doi.org/10.1155/2013/ 878295.
20. N.MD. Akram, M. Umamahesh N, A new validated RP-HPLC method for the determination of tenofovir disoproxil fumarate and tenofovir af in its bulk and pharmaceutical dosage forms., Journal of Chemical and Pharmaceutical Sciences,10(4);2017:54-59.
21. Dr. Srinivasa Rao A, Naveen Kumar G, Srilekha K, Dr. Aruna Kumari N. Stability indicating method for the simultaneous estimation of tenofovir, tenofovir disoproxil fumarate and efavirenz in pure and pharmaceutical dosage form by RP-HPLC, 5(5); 2016:188-200.
22. Umesh Maniyar, M. V. Katariya, Kishor Kumar Koshe, Gopal Karva, Sushil Jaiswal, Stability indicating RP-HPLC method for the simultaneous estimation of efavirenz, tenofovir disoproxil fumarate and tenofovir disoproxil fumarate in combined pharmaceutical dosage form, World journal of pharmacy and pharmaceutical sciences, 5( 6); 2016: 1180-1198.
23. Sk Mastanamma, D Venkata Reddy, P Saidulu and M Varalakhimi, Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of tenofovir disoproxil fumarate tenofovir alafenamide bulk and their combined dosage form, Journal of Chemical and Pharmaceutical Research, 9(9);2017:70-80.
24. Som Shankar Dubey and Mahesh Duggirala, High performance liquid chromatography with PDA detector for combined determination of tenofovir disoproxil fumarate, tenofovir and efavirenz, Der Pharmacia Lettre, 7 (10);2015:85-91.
25. P.D. Hamarapurkar, Abhijeet N. Parate., HPLC method for the determination of tenofovir disoproxil fumarate and related degradation substances., journal of chromatographic science, https://academic.oup.com/chromsci/article/51/5/419/326539.
26. MD Abdul Sattar and Suneetha Achanta, Analytical Method Development and validation for the determination of tenofovir disoproxil fumarate and tenofovir disoproxil fumarate using reverse phase hplc method in bulk and tablet dosage form, Journal of pharmaceutical science and research,10(5); 2018: 1207-1212.
27. Raghu Ram Jampala, V. Kiran Kumar, Appala Raju Nemala, Development and Application of Liquid Chromatographic Method for Simultaneous Determination of Elvitegravir, Tenofovir Disoproxil Fumarate, Emtricitabine, and Cobicistat in Fixed Dosage Form, Pharmaceutical Methods. 5 (1);2014: 7-13.
28. Vasanti M. Suvarna and Preeti C. Sangave, Development and validation of stability indicating rp-hplc method for tenofovir solid lipid nanoparticles, International Journal of Pharmaceutical Sciences and Research, 8(2); 2017: 658-666.
29. Dunge Ashenafi, Varalaxmi Chintam, Daisy van Veghel, Sanja Dragovic, Jos Hoogmartens, Erwin Adams, Development of a validated liquid chromatographic method for the determination of related substances and assay of tenofovir disoproxil fumarate, Journal of Separation. Sciences. 33; 2010: 1708–1716.
30. R. Srinivasan, K. Lardu Mary, G. Lakshmana, D. Rajesh kumar, B. Rangani, Method development and validation of Emtricitabine and Tenofovir Disoproxil Fumarate in combined dosage form by UV spectroscopy and RP-HPLC, International journal of pharmacy and analytical research 3(4); 2014: 414-421.
31. J. Saminathan and T. Vetrichelvan, Development and validation of HPTLC method for simultaneous estimation of tenofovir disoproxil fumarate, rilpivirine and tenofovir disoproxil fumarate in combined dosage form, Bangladesh Pharmaceutical Journal 19(1);2016: 114-121.