Simultaneous estimation of emtricitabine, tenofovirdisoproxilfumarate and rilpivirine in pharmaceutical dosage form by using rp-hplc

Kanchan Sunil Nautiyal; Indira Priyadarshini G; Sukhanya P

doi:10.37022/jis.v6i4.66

Kanchan Sunil Nautiyal Gitam University, Goregaon West, Mumbai, Maharashtra - 400104, India
G. Indira Priyadarshini Hindu College of Pharmacy, Amaravathi Road, Guntur – 522002, A.P., India
P. Sukhanya Hindu College of Pharmacy, Amaravathi Road, Guntur – 522002, A.P., India

DOI https://doi.org/10.37022/jis.v6i4.66

Abstract

The study describes method development and subsequent validation of RP-HPLC method for simultaneous estimation of emtricitabine, tenofovir disoproxil fumarate and rilpivirine in combined tablet dosage forms. Chromatographic separation was achieved on a hypersilBDSC18 column (250 mm x 4.6 mm, 5 µm) using a mobile phase consisting of (45:55 v/v) buffer: acetonitrile at a flow rate of 1 mL/min. The detection wavelength is 280 nm. The retention times of emtricitabine, tenofovirdisoproxil fumarate and rilpivirine were found to be 2.692, 4.402 min and 5.725 min respectively. The developed method was validated as per ICH guidelines. The developed and validated method was successfully used for the quantitative analysis of emtricitabine,tenofovirdisoproxilfumarate and rilpivirine in tablet dosage forms.

Keywords: HPLC, emtricitabine, tenofovirdisoproxilfumarate, rilpivirine, Validation

References

1. Drug Information of Emtricitabine - http://www.rxlist.com/emtriva-drug.html
2. Drug Information of Emtricitabine -http://www.drugbank.ca/drugs/DB00879/
3. Drug Information of Tenofovir - http://www.rxlist.com/viread-drug.htmL
4. Drug Information of Tenofovir - http://www.drugbank.ca/drugs/DB00300
5. Drug Information of Rilpivirine - http://www.drugbank.ca/drugs/DB08864
6. Drug Information of Rilpivirine -http://www.rxlist.com/edurant-drug.htmL
7. Sharma R, Mehta K. Simultaneous Spectrophotometric estimation of Tenofovirdisoproxilfumarate and lamivudine in three component tablet formulation containing efavirenz. Indian journal of pharmaceutical sciences. 201072(4):527-530.
8. Suhel P, Baghel US, Rajesh P, Prabhakar D, Engla G, Nagar PN. Spectrophotometric Method Development and Validation for Simultaneous Estimation of Tenofoirdisoproxilfumarate and Emtricitabine in Bulk Drug and Tablet Dosage form. International Journal of Pharmaceutical and Clinical Research. 20091(1):28-30.
9. Raju NA, Begum S. Simultaneous RP-HPLC method for the estimation of the emtricitabine, tenofovirdisoproxilfumerate and efavirenz in tablet dosage forms. Research Journal of Pharmacy and Technology. 2008 1(4):522-525.
10. Raju NA, Rao JV, Prakash KV, Mukkanti K, Srinivasu K. Simultaneous estimation of tenofovirdisoproxil, emtricitabine and efavirenz in tablet dosage form by RPHPLC. Oriental Journal of Chemistry. 2008 24(2):645-650.
11. Raju NA, Begum S, Srinivasu K. Simultaneous estimation of Tenofovirdisoproxilfumerate, emtricitabine and efavirenz in tablet dosage forms by isocratic RP-HPLC. Journal of Pharmacy Research. 2009 2(6): 1103-1106.
12. Sharma R, Gupta P. Simultaneous Quantification and Validation of Emtricitabine and TenofovirDisoproxilFumarate in a Tablet Dosage Form. Eurasian Journal of Analytical Chemistry. 2009 4(3):276-284.
13. Kavitha KY, Geetha G, Hariprasad R, Venkatnarayana R, Subramanian G. Development And Validation of RP-HPLC Analytical Method for Simultaneous Estimation of Emtricitabine, Rilpivirine, TenofovirDisoproxilFumarate and its Pharmaceutical Dosage Forms. PharmacieGlobale. 2013 4(1): 1.
14. Sharma R, Gupta P. Simultaneous Quantification and Validation of Emtricitabine and TenofovirDisoproxilFumarate in a Tablet Dosage Form. Eurasian Journal of Analytical Chemistry. 2009 4(3):276-284.
15. Bapatla J, Sai N, Hari HD, Theja K, Ramalingam P, Reddy Y. Validated HPTLC Method for the Determination of Tenofovir as Bulk Drug and in Pharmaceutical Dosage Form. Pelagia Res Library. 20112:163-168.
16. Rezk, Naser L., Rustin D. Crutchley, and Angela DMKashuba. Simultaneous quantification of emtricitabine and tenofovir in human plasma using high-performance liquid chromatography after solid phase extraction.Journal of Chromatography B 2005 822(1): 201-208.
17. Delahunty T, Bushman L, Robbins B, Fletcher CV. The simultaneous assay of tenofovir and emtricitabine in plasma using LC/MS/MS and isotopicallylabeled internal standards. Journal of Chromatography B. 2009 877(20):1907-1914.
18. SparidansRW, Crommentuyn KM, SchellensJH, BeijnenJH. Liquid chromatographic assay for the antiviral nucleotide analogue tenofovir in plasma using derivatization with chloroacetaldehyde. Journal of Chromatography B. 2003 791(1):227-233.
19. El Barkil M, Gagnieu MC, Guitton J. Relevance of a combined UV and single mass spectrometry detection for the determination of tenofovir in human plasma by HPLC in therapeutic drug monitoring. Journal of Chromatography B. 2007 854(1):192-197.
20. Guideline IH. Validation of analytical procedures: text and methodology. Q2 (R1). 2005 Nov;1