A New Stability Indicating Analytical Method Development And Validation for The Quantitative Determination of Emitricitabine And Lamivudine By RP-HPLC
Abstract
A novel stability indicating, precise, accurate and ecofriendly reverse phase high performance liquid chromatographic method was developed and validated for the quantitative determination of Emtricitabine and Lamivudine in pure and pharmaceutical dosage forms. Estimation of drugs in this combination was done with a C18 column [Kromasil C18column. 5mm, 4.6´250 mm]using mobile phase of compositionMethanol and phosphate buffer (40:60 v/v, pH 4).The flow rate was 1.0 ml/min and the effluents were monitored at 261 nm. The retention time of LamivudineandEmtricitabine were2.810 min and 4.727 min respectively. The linearity was found to be 40-80mg/ml for Lamivudine and40-80mg/ml forEmtricitabine.The stability parameters were evaluated by injecting the stressed sample and it was proved that there was no degradants. The established method was validated according to ICH guidelines.
Keywords:
Emtricitabine, Lamivudine, RP-HPLC, Stability and Method Validation
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References
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2. Merck Index 14th edition, 2006, 9151 & 3568.
3. Indian Pharmacopeia 2014, 7th edition,Vol – 2 & 3, 1652 & 2834.
4. Z.M. Sayyed, Aijaz A. Sheikh, Zakirhussain A. Shaikh, S.A. Shinde, V.J. Chaware, K. R. Biyani:, “Development and Validation of Analytical Method for Simultaneous Estimation of Tenofovir and Emtricitabine in Pharmaceutical Dosage Forms by HPLC” International Journal of Pharmaceutics & Drug Analysis, 2016, 4 (1) 24 –29.
5. B. Venkateswara Rao, S. Vidyadhara, B. Nagaraju and SK. Jhonbi. A novel RP-HPLC method development and validation for the determination of Lamivudineand Emtricitabine in bulk and pharmaceutical formulations. International Journal of Pharmaceutical Sciences and Research, 2017, 8(5) 2168-2176.
6. Naresh Chandra Joshi, Pradeep Kumar and Rakesh Kumar Jat:, “Development and validation Of RP-HPLC method for the estimation of antiretroviral drugs and their Pharmaceutical Formulations” An International Research Journal, 2016, 7 (3) 152-165.
7. Ajay D. Mali and Uttam B:, More “RP-HPLC Method for Simultaneous estimation of Impurities from Emtricitabine and LamivudineTablet” international Journal of Pharmaceutical Sciences and Research, 2016, 7(4) 1662-1669.
8. Manasi Agashe, Rohit Chaudhari, Vaishali Shirsat:, “A Rapid Stability Indicating RP-HPLC Method and the Degradation Kinetics Data for the Simultaneous Estimation of Lamivudineand Emtricitabine” IJPPR International Journal of Pharmacy and Pharmaceutical Research, June 2015, 3(3) 145-159.
9. M.H. Abdelhay, A.A. Gazy, R.A. Shaalan, and H.K. Ashour:,“Selective RP-HPLC DAD Method for Determination of Tenofovir fumarate and Emtricitabine in Bulk Powder and in Tablets” Original Research Paper, 2015, 27(1) 41–54.
10. Akbar basha, D. Sireesha, D. Anil, Rajini Talla, M. Akifulhaque, S. Harshini, B. Vasudha:, “Method development and validation for simultaneous estimation of Lamivudineand emtricitabine in pharmaceutical dosage form by RP-HPLC method” International journal of innovative pharmaceutical sciences and research, 2015, 3(10) 1537-1545.
11. Bala Rami Reddy. Yenumula, Mutta Reddy. Singampalli and Bala Sekhara Reddy. Challa:, “Simultaneous Estimation of Emtricitabine and Lamivudinein tablet dosage form by Reverse Phase High-performance Liquid Chromatography” SOJ Chromatographic Science, 2015, 2-6.
12. K.Sujatha, T.SheelaRani K.AnandBabu, K.Kavitha, K.Chitra:, “RP-HPLC Method Development And Validation of Emtricitabine In Synthetic Mixture” World Journal of Pharmaceutical Research, June 2014, 3(6) 499-505.
13. Dr.R.srinivasan, K.Lurdhu Mary, G.Lakshmana, D.Rajesh Kumar, B.Rajini:, “Method development and validation of tenofoir disoproxil fumarate and emtricitabine in combined tablet dosage form by UV-spectrophotometry and RP-HPLC” International Journal of Pharmacy and Analytical Research,Oct-Dec-2014, 3(4) 414-421.
14. Vanitha C, Pradeep kumar P, Rajanisekhar V, Swarnalatha G, Sekar V:, “Simulataneous estimation of Emtricitabine and Lamivudinein a tablet dosage form by RP-HPLC Method” International Journal of Pharmaceutical Development & Technology, 2014, 4(4) 279-283.
15. M. Venkatesh, A.L.M.N. Sumanth1, P. Venkateswa Rao:, “Analytical Method development and validation of simultenious estimation of Tenofovir and Emtricitabine in bulk and Pharmaceutical dosage forms By Using RP-HPLC” Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry,2013, 1(2) 60-69.
16. Rao, Battula Sreenivasa, Nagaraju, Siva; Kiran, B.V:, “Development, Validation and Stress Degradation Studies of Emtricitabine and Tenofovir disoproxil fumerate by High Performance Liquid Chromatography” Asian Journal of Research in Chemistry, Oct 2013, 6(10) 936.
17. Viswanath V, Shanmugasundaram P, Ravichandiran V:, “RP-HPLC Method for the Simultaneous Estimation of Tenofovir disoproxil fumerate and Emtricitabine in Combined tablet dosage form” International Journal of Pharm Tech Research, July-Sept 2013, 5(3) 1186-1195.
18. Deepthin Komaroju, G. Nagarjuna Reddy, K. Dhanalakshmi:, “Method development and validation for simultaneous estimation of Emtricitabine and Lamivudinein Pure and Tablet Dosage Form by using RP-HPLC” International Journal of Pharma Research & Review, Oct 2013, 2(10) 1-11.
19. Rui Tan, Bo Yan, Jingchuan Shang, Junqing Yang, Wenxiang Huang, XiaoniZhong, Ailong Huang and Mingfeng Wang:, “New solid phase extraction reversed phase high performance liquid chromatography ultraviolet (RP-HPLC-UV) method for simultaneous determination of tenofovir and emtricitabine in Chinese population” African Journal of Pharmacy and Pharmacology, 2012, 6(26) 1890-1900.
20. Narendra Devanaboyina, Satyanarayana T and Ganga Rao B:, “HPLC Method development and validation for simultaneous estimation of Tenofovir and Emtricitabine in Combined Pharmacetuical dosge form” International Journal of Research in Pharmaceutical and Biomedical Sciences, 2012.
21. Budagamlavanya, Perumalla Hariprasad, Allumellu Venkatapraveen, Dudipala Prasannalakshmi, MaramRamireddy:, “Simultaneous estimation of emtricitabine and tenofovirdisproxilfumerate by HPLC method” Scholars Research Library, 2012, 4(6) 1855-1862.
22. B. SyamSundar, SubhashiniEdla:, “RP – HPLC Method Development and Validation for The Analysis of Tenofovuir in Pharmacetical Dosage Forms” Journal of atoms and molecules, 2011, 1(1) 32-40.
23. Prathiban c, BhagavanRaju M, Sudhakar M:, “A simple of RP-HPLC method for simultaneous estimation of tenofovir disoproxil fmarate and emtricitabine in tablet dosage form” International research journal of pharmacy, 2011, 2(12) 201-203.
24. B. Jayakar, M.V. Kumudhavalli, V.P.V.S. Koteswara Rao, C. Saravanan, R.Margret Chandira and Abhitej:, “Method development and validation for simulataneous estimation of emtricitabine and tenofovir disoproxil fumerate in pharmaceutical dosage form” Annals of Pharmacy and Pharmaceutical Sciences, October 2010, 1(2) 152-154.
25. Anandakumar Karunakaran, Kannan Kamarajan and Vetrichelvan Thangarasu:, “A Validated RP - HPLC Method for Simulataneous estimation of Emtricitabine and Lamivudinein Pure and in tablet dosage form” Pelagia Research Library Der Pharmacia Sinica, 2010, 1(2) 52-60.
Published
01-05-2020
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K VG, K T, P SP. A New Stability Indicating Analytical Method Development And Validation for The Quantitative Determination of Emitricitabine And Lamivudine By RP-HPLC. World Journal of Current Med and Pharm Research [Internet]. 2020May1 [cited 2024Dec.6];2(2):184-90. Available from: https://wjcmpr.com/index.php/journal/article/view/122
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