A novel validated RP-UPLC for the simultaneous estimation of Emtricitabine, Tenofovir Disoproxil Fumarate, Cobicistat and Elvitegravir in tablet dosage form

Main Article Content

Swapna Vemireddy
Gandla Kumaraswamy

Keywords

performance, method, specific

Abstract

The present study provides us a single analytical tool for the determination of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate in dosage forms. This method helps us to separate and detect the four active pharmaceutical ingredients in a single run. The objective is to develop and validate a simple Ultraphase liquid chromatography method for the simultaneous determination of emtricitabine, tenofovir disoproxil fumarate, elvitegravir and cobicistat in dosage tablets. For this method, an Agilent 1200, high performance liquid chromatography system, Acquity Ethylene Bridged Hybrid technology (BEH) C18, 1.7μ. 100 x 2.1 mm column was used. The gradient program was adjusted at 0.3 ml/min flow rate and 10 μl injection volumes were maintained. Detection wavelength of 260 nnm is found to specific and could able to provide precise area counts for each drug. Calibration curves depicting a proper linearity response from concentration versus area observed for each drug with correlation coefficients of greater than 0.99. The eluted compounds were monitored at 240 nm. The column oven temperature was maintained at 30°. The developed chromatographic method was validated for selectivity, linearity, precision, accuracy, sensitivity, robustness, and system suitability.

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References

1. Sweetman SC, editor. Martindale - The Complete Drug Reference. 36th ed., Vol. 1. London, UK: Pharmaceutical Press; 2009.
2. Gilead Sciences “New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA”, April 21; 2014.
3. Aids info Drug Database. Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Disoproxil Fumarate. Available from: https://www.aidsinfo. nih.gov/drugs/507/stribild/0/patient.
4. Highlights of Prescribing Information. STRIBILD® (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) Tablets, for oral use Initial U.S. Approval; 2012.
5. O’Neil MJ. The Merck Index-An Encyclopedia of Chemicals, Drugs, and Biological. 13th ed. Whitehouse Station, NJ: Published by Merck Research Laboratories; 2001. p. 1631-2.
6. Kamal AH, El-Malla SF, Hammad SF. A review on UV spectrophotometric methods for
simultaneous multicomponent analysis. Eur J Pharm Med Res 2016;3:348-60.
7. Elzanfaly ES, Saadn AS, Elaziz BA. A smart simple spectrophotometric method for simultaneous determination of binary mixtures. J Pharm Anal 2012;2:382-5.
8. Chaudhary J, Jain A, Saini V. Simultaneous estimation of multicomponent formulations by UV-visible spectroscopy: An overview. Int Res J Pharm 2011;2:81-3.
9. Soumya B, Kumar TM, Raghunandhan N. Simultaneous determination of tenofovir disoproxil fumarate and lamivudine by UV spectrophotometric method. Int J Pharm Pharm Sci Res 2012;2:9-15.
10. Himaja M, Kalpana J, Anbarasu C. Validated zero order and first order derivative spectrophotometric methods for in vitro analysis of tenofovir disoproxil fumarate tablets using azeotropic mixture. Int J Pharm Pharm Sci 2014;6:302-4.
11. AbdelHay MH, Gazy AA, Shaalan RA, Ashour HK. Simple spectrophotometric methods for determination of tenofovir fumarate and emtricitabine in bulk powder and in tablets. J Spectrosc 2013;2013:937409.
12. Ilango K, Sunitha PG. Development and validation of UV spectrophotometric methods for the simultaneous determination of emtricitabine and tenofovir in combined dosage form. J Pharm Res 2012;5:873-5.
13. Ghorpade SA, Sali MS, Kategaonkar AH, Patel DM, Choudhari VP, Kuchekar BS. Simultaneous determination of emtricitabine and tenofovir by area under curve and dual wavelength spectrophotometric method. J Chil Chem Soc 2010;55:115-7.
14. Choudhari VP, Parekar SR. Development and validation of UV-visible spectrophotometric baseline manipulation method for simultaneous quantitation of tenofovir disoproxil fumarate and emtricitabine in pharmaceutical dosage form. J Spectrosc 2013;2013:146580.
15. Venkatesan S, Kannappan N. Simultaneous spectrophotometric method for determination of emtricitabine and tenofovir disoproxil fumarate in three-component tablet formulation containing rilpivirine hydrochloride. Int Sch Res Notices 2014;2014:541727.
16. Blessy M, Patel RD, Prajapati PN, Agrawal YK. Development of forced degradation and stability indicating studies of drugs—A review. J Pharm Anal 2014;4:159-65.