Barath M, Chandan R. S, Maruthi R, N Paramakrishnan
Barath M, Chandan R. S*, Maruthi R, N Paramakrishnan
JSS College of Pharmacy, Mysuru, JSS Academy of Higher Education and Research, Sri Shivarathreeshwara Nagara, Mysuru Karnataka, India 570015.
Volume - 14,
Issue - 7,
Year - 2021
An ultra-fast liquid chromatography (RP-UFLC) approach was processed for the estimation of ETR, which is quick, responsive, reliable, and inexpensive. Work on the Phenomenex Kinetex C18 column (250x 4,6mm. 5µ) was carried out with MeOH and acetonitrile in the mobile phase ratio of (60:40v/v) at 1.0mL/min. With a PDA detection system, the eluent was tracked at 311nm. ETR elutes at a persistence time of 3.226 min. The proposed method gives linearity of concentration from 1 to 5µg/mL, with the value of R2 at 0.9942%. For the proposed method, LOD and LOQ are measured as 0.02 and 0.073µg/mL. The pharmaceutical drug included acidic, alkaline, corrosion, Ultraviolet, and heat stress stipulations. The deterioration material was nicely resolved from ETR peaks, which showed the reliability of the process. The approach has been tested with respect to process adequacy, linearity, reliability, and robustness, as per ICH guidelines.
Cite this article:
Barath M, Chandan R. S, Maruthi R, N Paramakrishnan. Analytical Method Development and Validation of Etravirine by RP-UFLC. Research Journal of Pharmacy and Technology. 2021; 14(7):3537-2. doi: 10.52711/0974-360X.2021.00613
Barath M, Chandan R. S, Maruthi R, N Paramakrishnan. Analytical Method Development and Validation of Etravirine by RP-UFLC. Research Journal of Pharmacy and Technology. 2021; 14(7):3537-2. doi: 10.52711/0974-360X.2021.00613 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-7-10
4. Blessy MR, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs—a review. Journal of Pharmaceutical Analysis. 2014 Jun 1;4(3): 159-65.
5. Rebiere H, Mazel B, Civade C, Bonnet PA. Determination of 19 antiretroviral agents in pharmaceuticals or suspected products with two methods using high-performance liquid chromatography. Journal of Chromatography B. 2007 May 1;850(1-2): 376-83.
6. Djerada Z, Feliu C, Tournois C, Vautier D, Binet L, Robinet A, Marty H, Gozalo C, Lamiable D, Millart H. Validation of a fast method for quantitative analysis of elvitegravir, raltegravir, maraviroc, etravirine, tenofovir, boceprevir and 10 other antiretroviral agents in human plasma samples with a new UPLC-MS/MS technology. Journal of Pharmaceutical and Biomedical Analysis. 2013 Dec 1;86: 100-11.
7. Fayet A, Béguin A, Zanolari B, Cruchon S, Guignard N, Telenti A, Cavassini M, Günthard HF, Buclin T, Biollaz J, Rochat B. A LC–tandem MS assay for the simultaneous measurement of new antiretroviral agents: Raltegravir, maraviroc, darunavir, and etravirine. Journal of Chromatography B. 2009 Apr 15;877(11-12): 1057-69.
8. D'Avolio A, Baietto L, Siccardi M, Sciandra M, Simiele M, Oddone V, Bonora S, Di Perri G. An HPLC-PDA method for the simultaneous quantification of the HIV integrase inhibitor raltegravir, the new nonnucleoside reverse transcriptase inhibitor etravirine, and 11 other antiretroviral agents in the plasma of HIV-infected patients. Therapeutic Drug Monitoring. 2008 Dec 1;30(6): 662-9.
9. Reddy BR, Jyothi G, Reddy BS, Raman NV, Reddy KS, Rambabu C. Stability-Indicating HPLC method for the determination of darunavir ethanolate. Journal of Chromatographic Science. 2012 Oct 24;51(5): 471-6.
10. Phase df. Analytical method development and validation of etravirine in its bulk dosage form by using reverse phase high performance liquid chromatography method as per international conference on harmonisation guidelines. Asian j pharm clin res. 2015; 8(2): 147-50.
11. Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Etravirine.
12. Bhavyasri K, Balaram VM, Nageswarao R, Rambabu D, Goud ES, Ajitha M. Development and validation of forced degradation studies of Raltegravir using RP-HPLC and characterization of degradants by LC-MS/MS. Journal of Pharmaceutical Sciences and Research. 2015 Sep 1; 7(9): 685.
13. Simiele M, Pensi D, Pasero D, Ivaldi F, Rinaldi M, Di Perri G, Ranieri VM, D'Avolio A. Development and validation of an ultra-performance liquid chromatography tandem mass method for sildenafil and N-desmethyl sildenafil plasma determination and quantification. Journal of Chromatography B. 2015 Sep 15; 1001: 35-40.
14. Bennetto-Hood C, Tabolt G, Savina P, Acosta EP. A sensitive HPLC–MS/MS method for the determination of dolutegravir in human plasma. Journal of Chromatography B. 2014 Jan 15; 945:225-32.
15. Archibald TL, Murrell DE, Brown SD. Chromatographic methods in HIV medicine: application to therapeutic drug monitoring. Biomedical Chromatography. 2018 Feb;32(2): e4170.
16. Annapurna MM. Stability indicating reverse-phase high-performance liquid chromatography method for the determination of Raltegravir in bulk and pharmaceutical formulation. International Journal of Green Pharmacy. 2018 May 18; 12(01).