Analytical Method Development and Validation of Stability Indicating Rp-Hplc Method for the Simultaneous Estimation of Abacavir and Dolutegravir
Keywords:
Abacavir, Dolutegravir, HPLC, Development, ValidationAbstract
Special, effective high pressure liquid chromatography method has been developed for the simultaneous quantification of Abacavir and Dolutegravir.By using Waters HPLC e-2695 quaternary pump with a PDA detector of 2998 instrument the chromatographic separation of Abacavir and Dolutegravir was achieved on the column of Inertsil ODS150X4.6mm, 3.5µ using an isocratic elution with a buffer containing 0.1percentformic acid and acetonitrile at a rate of 30:70 as a mobile phase with a flow rate of 1 ml/min at ambient temperature. A detector wavelength of 236 nm utilizing the PDA detector were given in the instrumental settings. The linearity was studied between the concentration range of 30-450 µg/ml of Abacavir and 5-75 µg/ml of Dolutegravir were injected.The plotted calibration curves were linear with a regression coefficient of R2> 0.999, indicates that the linearity was with in the limit. As a part of method validation the parameters like specificity, linearity, accuracy, ruggedness, robustness were determined and the results were found to be within the allowable limit. The method developed was found to be applicable to routine analysis and to be used for the measurement of both active pharmaceutical ingredients (i.e, Abacavir and Dolutegravir).Validation of the proposed method was carried out according to an International Conference on Harmonization (ICH) guidelines
Downloads
Metrics
References
Duncan CJ, Russell RA, Sattentau QJ. High multiplicity HIV-1 cell-to-cell transmission from macrophages to CD4+ T cells limits antiretroviral efficacy. AIDS 2013; 27(14): 2201–6.
Eisinger RW, Dieffenbach CW, Fauci AS. (February 2019). HIV Viral Load and Transmissibility of HIV Infection: Undetectable Equals Untransmittable. JAMA 2019; 321(5): 451–2.
Claessens Yann-Erick, Chiche Jean-Daniel, Mira Jean-Paul, Cariou Alain. Bench-to-bedside review: Severe lactic acidosis in HIV patients treated with nucleoside analogue reverse transcriptase inhibitors. Critical Care 2003; 7(3): 226–32.
Das Kalyan, Sarafianos SG, Clark Jr AD, Boyer PL, Hughes SH, Arnold E. Crystal structures of clinically relevant Lys103Asn/Tyr181Cys double mutant HIV-1 reverse transcriptase in complexes with ATP and non-nucleoside inhibitor HBY 097. J Mol Biol 2007; 365(1): 77–89.
Yuen GJ, Weller S, Pakes GE. A review of the pharmacokinetics of abacavir. Clinical Pharmacokinetics 2008; 47(6): 351–71.
Lie, J.D PharmD BCACP, Tu K N PharmD BCPS CGP, Shen D D, Wong B M.Pharmacological Treatment of Insomnia. Pharmacy and Therapeutics Journal 2015; 40(11): 759–68, 71.
Mhorpy MJ.Classification of sleep disorders. Neurotherapeutics 2012; 9(4): 687–701.
Roth J, Blatteis CM. Mechanisms of fever production and lysis: Lessons from experimental LPS fever. Comprehensive Physiology 2014; 4(4): 1563–604.
Black C A. Delayed type hypersensitivity: Current theories with an historic perspective. Dermatology Online Journal 1999; 5(1): 7.
Tilg H, Cani PD, Mayer EA. Gut microbiome and liver diseases. Gut 2016; 65(12): 2035–44.
Yu B, Mamedov R, Fuhler GM, Peppelenbosch MP.Drug Discovery in Liver Disease Using Kinome Profiling. International Journal of Molecular Sciences 2021; 22(5): 2623.
Santini A, Ronchi D, Garbellini M, Piga D, Protti A. Linezolid-induced lactic acidosis: the thin line between bacterial and mitochondrial ribosomes. Expert Opinion on Drug Safety. 2017; 16(7): 833–43.
DeFronzo R, Fleming GA, Chen K, Bicsak TA.Metformin-associated lactic acidosis: Current perspectives on causes and risk. Metabolism: Clinical and Experimental 2016; 65(2): 20–9.
Blair HA, Dhillon S. Omega-3 carboxylic acids (Epanova): a review of its use in patients with severe hypertriglyceridemia. Am J Cardiovasc Drugs 2014; 14: 393–400.
Beigneux Anne P, Miyashita Kazuya, Ploug Michael, Blom Dirk J, Ai Masumi, Linton Macrae F,et al. Autoantibodies against GPIHBP1 as a Cause of Hypertriglyceridemia. NEJM 2017; 376(17): 1647–58.
Polyzos SA, Perakakis N, Mantzoros CS. Fatty liver in lipodystrophy: A review with a focus on therapeutic perspectives of adiponectin and/or leptin replacement. Metabolism: Clinical and Experimental 2019; 96: 66–82.
Meral R, Ryan BJ, Malandrino N, Jalal A, Neidert AH, Muniyappa R, et al.Fat Shadows From DXA for the Qualitative Assessment of Lipodystrophy: When a Picture Is Worth a Thousand Numbers. Diabetes Care 2018; 41(10): 2255–8.
Shiber JR, Santana J. Dyspnea. Med Clin North Am 2006; 90(3): 453–79.
Torres M, Moayedi S. Evaluation of the acutely dyspneic elderly patient. Clin Geriatr Med 2007; 23(2): 307–25, vi.
Mulamoottil VA, Nayak A, Jeong LS. Recent Advances in the Synthesis of Carbocyclic Nucleosides via Ring‐Closing Metathesis. Asian Journal of Organic Chemistry 2014; 3(7): 748–61.
Irwin K, Renzette N, Kowalik T, Jensen J.Antiviral drug resistance as an adaptive process. Virus Evolution 2016; 2(1): vew014.
Diprose P, Deakin C D, Smedley J.Ignorance of post-exposure prophylaxis guidelines following HIV needlestick injury may increase the risk of seroconversion. British Journal of Anaesthesia 2000; 84(6): 767–70.
DuPont HL. Acute infectious diarrhea in immunocompetent adults. The New England Journal of Medicine 2014; 370(16): 1532–40.
Umpierrez Guillermo E, Pasquel Francisco J. Management of Inpatient Hyperglycemia and Diabetes in Older Adults. Diabetes Care 2017; 40(4): 509–17.
Luna B, Feinglos MN. Drug-induced hyperglycemia. JAMA 2001; 286(16): 1945–8.
May JR, Dolen WK.Management of Allergic Rhinitis: A Review for the Community Pharmacist. Clinical Therapeutics 2017; 39(12): 2410–9
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution 4.0 International License.
You are free to:
- Share — copy and redistribute the material in any medium or format
- Adapt — remix, transform, and build upon the material for any purpose, even commercially.
Terms:
- Attribution — You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use.
- No additional restrictions — You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits.
