Method Development and Validation for Multicomponent Analysis of Emtricitabine and Ritonavir in Bulk Drug by RP-HPLC
Abstract
A simple, sensitive, economic and specific reverse phase liquid chromatographic method was developed for the simultaneous estimation of Emtricitabine and Ritonavir in bulk drug. Chromatographic conditions consisted of C-18 Column (Shim-pack) 250 x 4.6 mm, particle size 5 µm , mobile phase combination of methanol and water (80:20), flow rate 1ml per minutes, run time 15 minutes and UV detection at 251nm. . The retention time for Emtricitabine and Ritonavir were found to be 3.25 and 7.8 min and average percentage recoveries 99.42% and 99.63% respectively. The validation parameters were found to comply with ICH guidelines. These methods can be further employed in future for the routine determination of Emtricitabine and Ritonavir in bulk drug and formulation.
Keyword: Emtricitabine, Ritonavir, RP-HPLC, accuracy and linearity.
Keywords:
Emtricitabine, Ritonavir, RP-HPLC, accuracy and linearityDOI
https://doi.org/10.22270/jddt.v10i6.4400References
Gu SX, Lu HH, Liu GY, Ju XL, Zhu YY. Advances in diarylpyrimidines and related analogues as HIV-1 nonnucleoside reverse transcriptase inhibitors. European Journal of Medicinal Chemistry. 2018 Oct 5; 158:371-92.
Simon V, Ho DD, Karim QA. HIV/AIDS epidemiology, pathogenesis, prevention, and treatment. The Lancet. 2006 Aug 5; 368(9534):489-504.
Li X, Zhang L, Tian Y, Song YN, Zhan P, Liu X. Novel HIV-1 non-nucleoside reverse transcriptase inhibitors: a patent review (2011–2014). Expert opinion on therapeutic patents. 2014 Nov 1; 24(11):1199-227.
Palella Jr FJ, Delaney KM, Moorman AC, Loveless MO, Fuhrer J, Satten GA, Aschman DJ, Holmberg SD, HIV Outpatient Study Investigators. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. New England Journal of Medicine. 1998 Mar 26; 338(13):853-60.
Triphathi KD. Essential of medical pharmacology. 6th ed. Jaypee brothers medical publishers. (2009): pg. 202.
Gunthard HF, Saag MS, Benson CA, et al. Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2016 recommendations of the International Antiviral Society-USA Panel. JAMA 2016; 316: 191–210
https://www.drugbank.ca/drugs/DB00879
https://pubchem.ncbi.nlm.nih.gov/compound/Emtricitabine
https://www.drugbank.ca/drugs/DB00503
https://pubmed.ncbi.nlm.nih.gov/8891466/
Backett AH, Stenlake JB, Practical of pharmaceutical chemistry. 4th ed. New Delhi. CBS publishers & distributers. 2005: p. 284.
Lloyd S R, Joseph J et al. Practical HPLC method development. 2nd ed. Jhon Willy and Sons, New York: p. 653
Snyder LR, Kirkland JJ, Glajch JL. Practical HPLC method development. John Wiley & Sons; 2012 Dec 3.
Hema SR. A Review On New Analytical Method Development And Validation By Rp-HPLC. Int Res J Pharm Biosci. 2017; 4:41-50.
Ravisankar P, Navya CN, Pravallika D, Sri DN. A review on step by-step analytical method validation. IOSR J Pharm 2015; 5:7-19.
https://www.britannica.com/science/chromatography/Methods
http://www.mournetrainingservices.co.uk/resources#hplc_book
https://www.ich.org/page/quality-guidelines
Gill MS, Hassan SS, Ahemad N. Evolution of HIV-1 reverse transcriptase and integrase dual inhibitors: recent advances and developments. European journal of medicinal chemistry. 2019 Oct 1; 179:423-48.
Rezaei M, Ramazani A, Hokmabadi F. Simultaneous Estimation and Validation of Tenofovir Disoproxil Fumarate, Emtricitabine and Efavirenz by RP-HPLC Method in Combined tablet Dosage Form. Current Pharmaceutical Analysis. 2019 Oct 1; 15(6):561-7.
Kokkirala TK, Suryakala D. RP-HPLC method development and validation for the estimation of Emtricitabine, Bictegravir and Tenofovir alafenamide in bulk and pharmaceutical dosage form. Journal of Taibah University for Science. 2019 Dec 11; 13(1):1137-46.
Kalamkar CS, Bhawar SB. Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Tenofovir Alafenamide Fumarate and Emtricitabine in Bulk and Tablet Dosage Form. Journal of Drug Delivery and Therapeutics. 2019 Jun 15; 9(3-s):243-7.
Kale RN. A review on analytical methods for estimation of tenofovir disoproxil fumarate and emtricitabine in bulk and pharmaceutical dosage forms. International Journal of Pharmaceutical and Biological Science Archive. 2019 Jun 16; 7(3).
Ibrahim AE, Saraya RE, Saleh H, Elhenawee M. Development and validation of eco-friendly micellar-HPLC and HPTLC-densitometry methods for the simultaneous determination of paritaprevir, ritonavir and ombitasvir in pharmaceutical dosage forms. Heliyon. 2019 Apr 1; 5(4):e01518.
Sri KV, Deepthi S, Madhuri M, Aishwarya PV. Development and Validation of UV Spectroscopic by Q-absorption Ratio, RP-HPLC Method for Simultaneous Estimation of Atazanvir and Ritonavir in bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2019; 9(3):138-50.
Ayeen FQ, Yasmeen R, Badar H. Development and Validation of RP-HPLC Method for Determination of Ritonavir and Lopinavir. Research Journal of Pharmacy and Technology. 2019; 12(7):3413-7.
Rathnasamy R, Karuvalam RP, Pakkath R, Kamalakannan P, Sivasubramanian A. RP-HPLC Method Development and Method Validation of Lopinavir and Ritonavir in Pharmaceutical Dosage Form. Am J Clin Microbiol Antimicrob. 2018; 1(1):1002.
Uppalapati Y, Ghosh B, Deshpande K, Tadimarri VS, Method Development and Validation for the Simultaneous Estimation of Emtricitabine and Tenofovir in Pharmaceutical Dosage Forms by RP-HPLC. J Drug Dev Del. 2018; 1(1):07-12
Ashok G, Sumanta M. Development and Validation of Stability Indicating Method for the Simultaneous Quantification of Emtricitabine, Tenofovir Disoproxil Fumarate and Rilpivirine Hydrochloride in Pharmaceutical Dosage Forms by RP-HPLC. 2018, 15:175183.
Akram N, Umamahesh M. A New Validated RP-HPLC Method for the Determination of Emtricitabine and Tenofovir AF in its Bulk and Pharmaceutical Dosage Forms. Journal of Chemical and Pharmaceutical Sciences. 2017; 10(4):2349-8552.
Badgujar BP, Mahajan MP, Sawant SD. development and validation of RP-HPLC method for the simultaneous estimation of tenofovir alafenamide and emtricitabine in bulk and tablet dosage form. International Journal of Chem Tech Research. 2017; 10(5):731-9
Gummaluri RK, Parthasarathi TV, Anjanamadhulika G. Simultaneous method for determination of emtricitabine, tenofovir disoproxil fumarate, elvitegravir and cobicistat in tablets by HPLC. Indian Journal of Pharmaceutical Sciences. 2016 Jun 28; 78(4):532-7.
Premij R. Ritonavir literature review. 2015 May ; 276059436
Venkatesan S, Kannappan N. Simultaneous spectrophotometric method for determination of emtricitabine and tenofovir disoproxil fumarate in three-component tablet formulation containing rilpivirine hydrochloride. International scholarly research notices.
Ramaswamy A, Das S.A. Development and validation of analytical method for quantitation of Emtricitabine, Tenofovir, Efavirenz based on HPLC. Arabian Journal of Chemistry. 2014; 11(2):1-7.
Rao BV, Vidyadhara S, Babu RR, Kumar BP, Kumar GK. Analytical method development and validation for simultaneous estimation of lopinavir and ritonavir by RP-HPLC 2014 June.
Sri KV, Madhuri M, Jain GV, Suresh K. Rapid RP-HPLC Method for Quantitative Determination of Emtricitabine in Bulk and Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2014; 7(8):897-901.
Trivedi CD, Mardia RB, Suhagia BN, Chauhan SP. Development and validation of spectrophotometric method for the estimation of ritonavir in tablet dosage form. International Journal of Pharmaceutical Sciences and Research. 2013 Dec 1; 4(12):4567.
Pawar DS, Dole M, Sawant S, Salunke JM. Development and validation of RP-HPLC method for the simultaneous estimation of Atazanavir sulphate and Ritonavir in bulk and formulations. International Journal of Pharmacy and Pharmaceutical Sciences. 2013; 5(Suppl 3):905-9.
Vasavi N, Patan A. Method development and validation for the simultaneous estimation of Atazanavir and Ritonavir in tablet dosage form by RP-HPLC. Indian Journal of Research in Pharmacy and Biotechnology. 2013 Nov 1; 1(6):808.
Varaprasad B, Baba H, Ravikumar A, Vijaykumar G. Development method validation of RP-HPLC method for simultaneous determination of lopinavir and ritonavir in bulk and formulation dosage. International Research Journal of Pharmaceutical and Applied Sciences. 2012 Aug 31; 2(4):84-90.
Chiranjeevi K, Channabasavaraj KP, Lakshminarayana B, Kumar BK. Development and validation of RP-HPLC method for quantitative estimation of ritonavir in bulk and pharmaceutical dosage forms. International Journal of Pharmaceutical Sciences and Research. 2011 Feb 1; 2(2):336.
Ponnilavarasan I, Rajasekaran A, Dharuman JG, Kalaiyarasi D, Senthilkumar M. RP–HPLC method for simultaneous estimation of antiretroviral drugs lopinavir and ritonavir in tablet dosage form. Digest journal of nanomaterials and biostructures. 2010 Jul 1; 5(3):771-8.
Walson PD, Cox S, Utkin I, Gerber N, Crim L, Brady M, Koranyi K. Clinical use of a simultaneous HPLC assay for indinavir, saquinavir, ritonavir and nelfinavir in children and adults. Therapeutic drug monitoring. 2003 Dec 1; 25(6):650-6.
Published


How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).