Published
2024-01-25
Issue
Section
Original Research Article
License
The Author(s) warrant that permission to publish the article has not been previously assigned elsewhere.
Author(s) shall retain the copyright of their work and grant the Journal/Publisher right for the first publication with the work simultaneously licensed under:
OA - Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). This license allows for the copying, distribution and transmission of the work, provided the correct attribution of the original creator is stated. Adaptation and remixing are also permitted.
This license intends to facilitate free access to, as well as the unrestricted reuse of, original works of all types for non-commercial purposes.
Development and validation of stability indicating methods for the simultaneous estimation of antiviral drugs Darunavir and Ritonavir By RP-HPLC
Radha Khambhampati
Department of Pharmacy, School of Pharmacy, Anurag University
Sireesha Dodda
Department of Pharmacy, School of Pharmacy, Anurag University
Rajendra Kumar Jadi
Department of Pharmacy, School of Pharmacy, Anurag University
Keywords: Darunavir, Ritonavir, RP-HPLC, Method development, Validation
References
1. Tegeli V, Birajdar A, Matole V. UV spectrophotometric method development and validation of darunavir in bulk and solid dosage form. Research Journal of Pharmacy and Technology 2021; 14(6): 3262-3264. doi: 10.52711/0974-360x.2021.005672. Gandla K, Lalitha R, Kumar DV, et al. Analytical method development and validation for the simultaneous estimation of ledipasvir and sofosbuvir in bulk and it's dosage form by RP-HPLC. International Journal of Pharmaceutics and Drug Analysis 2020; 8(4): 6-15.
3. Raju P, Thejomoorthy K, Prasanna PS. Development and validation of new analytical method for the simultaneous estimation of darunavir and ritonavir in pharmaceutical dosage form. International Journal of Indigenous Herbs and Drugs 2021: 49-57. doi: 10.46956/ijihd.vi.157
4. Nimje H, Kore P, Wankhede S, et al. Simultaneous estimation of darunavir ethanolate and ritonavir in combined dosage form. International Journal of Academic Research and Development 2017; 2(6): 218-222.
5. Bana AA, Patel P, Mehta PJ. Forced degradation study of darunavir ethanolate and ritonavir combination in acidic, basic, and oxidative conditions establishing degradation products. International Journal of Pharmaceutical Sciences and Research 2020; 11(11): 5875-5883.
6. Reddy BVR, Jyothi G, Reddy BS, et al. Stability indicating HPLC method for the determination of darunavir ethanolate. Journal of Chromatographic Science 2012, 51(5): 471-476. doi: 10.1093/chromsci/bms165
7. Anuraddha R, Chabukswar ASG. Development and Validation of stability indicating HPLC Method for estimation of darunavir. Journal of Drug Delivery and Therapeutics 2019; 9(4): 65-71.
8. Dhiwar P, Dumbre R, Gowekar N. Development and validation of stability indicating RP-HPLC method for Darunavir and Ritonavir in pharmaceutical dosage form. World Journal of Pharmaceutical Research 2020; 9(12): 798-820.
9. Rao NM, Sankar DG. Stability indicating RP-HPLC, lamivudine, tenofovir, darunavir and ritonavir. Indian Journal of Pharmaceutical Sciences 2016; 78(6): 755-762.
10. Prathap B, Haribaskar V, Kumar B, et al. Stability indicating RP-HPLC method for simultaneous estimation of Ritonavir and Darunavir in bulk and its synthetic mixture. Journal of Global Trends in Pharmaceutical Sciences 2018; 9(2): 5549-5560.
11. Paul K, BH JG, Shankar SJ, et al. Development and validation of simplified RP-HPLC method for quantification of Darunavir in commercial tablets. Materials Today: Proceedings 2021; 47: 4155-4161. doi: 10.1016/j.matpr.2021.04.444
12. Grace PL, Parthiban C. Analytical method development and validation for the simultaneous estimation of Darunavir and Ritonavir by RP-HPLC method. World Journal of Pharmaceutical Sciences 2022; 10(01): 32-40. doi: 10.54037/wjps.2022.100103
13. Bhavyasri K, Sreshta M, Sumakanth M. Simultaneous method development, validation and stress studies of darunavir and ritonavir in bulk and combined dosage form using UV spectroscopy. Scholars Academic Journal of Pharmacy 2020; 9(8): 244-252. doi: 10.36347/sajp.2020.v09i08.003
14. Kavitha AN, Raman D, Janaki RK. A new validated RP-HPLC method for the estimation of darunavir ethanolate in bulk and tablets. Asian Journal of Pharmaceutics 2020;14 (4): 652-660.
15. Bichala PK, sharma R, Kumar N, et al. Analytical method development and validation for the simultaneous estimation of darunavir and cobicistat by RP- HPLC method. International Journal of Research in Pharmacy and Chemistry. 2020, 10(1). doi: 10.33289/ijrpc.10.1.2020.10(28)
16. Hemant KJ, Jadhav US. Development and validation of RP HPLC method for estimation of darunavir ethanolate in bulk and tablets. International Journal of Pharmacy and Pharmaceutical Sciences 2015;7(10):386-389.
17. Kumar GS, Kumar MB. Development and Validation of RP-HPLC Method for the simultaneous determination of Nirmatrelvir and Ritonavir in bulk and pharmaceutical formulation. Research Journal of Chemistry and Environment. 2023, 27(4): 120-127. doi: 10.25303/2704rjce1200127
18. Jitta SR, Bhaskaran NA, Kumar L, et al. Development and validation of RP-HPLC method for quantification of total, free and entrapped ritonavir in lipid nanocarriers and drug content of film coated fixed dose formulation. Indian Journal of Pharmaceutical Education and Research 2022; 56(3s): s547-s558. doi: 10.5530/ijper.56.3s.164
19. Deshpande P, Butle S. Development and validation of stability-indicating HPTLC method for determination of darunavir and ritonavir. International Journal of Pharmacy and Pharmaceutical Sciences 2015; 7(6): 66-71.
20. Bhaskaran NA, Kumar L, Reddy MS, et al. An analytical quality by design approach in RP-HPLC method development and validation for reliable and rapid estimation of irinotecan in an injectable formulation. Acta Pharmaceutica 2021 ; 71(1): 57-79. doi: 10.2478/acph-2021-0008
21. ICH, Validation of Analytical Procedures; Methodology, Q2 (R1), International Conference on Harmonization, IFMA, Geneva, 1996.
22. Rao CP, Rao JS. Stability indicating RP-HPLC method for simultaneous determination of darunavir and cobicistat in bulk and pharmaceutical dosage form. World Journal of Pharmaceutical Sciences 2019; 7(3):187–198.
23. Swapna B, Kiran G, Vasudha B, Kumar JR. Stability indicating RP-HPLC method for simultaneous estimation of betamethasone dipropionate and calcipotriene in bulk and pharmaceutical dosage form. Biointerface Research in Applied Chemistry 2018; 8(1): 3089–3094.