DEVELOPMENT AND VALIDATION OF STABILITY INDICATING SIMULTANEOUS UVSPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE, COBICISTAT, AND ELVITEGRAVIR IN PURE AND PHARMACEUTICAL DOSAGE FORM


Harini U, Pawar Akm

Abstract


 Objective: The objective of this research work was to develop and validate a simple, precise, and accurate new ultraviolet-spectrophotometric method for the simultaneous estimation of emtricitabine (EMT), tenofovir disoproxil fumarate (TDF), cobicistat (COB), and elvitegravir (ELV) in pure and pharmaceutical marketed dosage form (stribild).

Methods: Simultaneous equation method (Vierordt’s method) was developed for simultaneous determination of several mixtures containing two or more absorbing drugs (p, q, r, and s) each of which absorbs at the λ max of the other. Forced degradation studies were also conducted, and the drugs were subjected to various stress conditions such as acid hydrolysis, base hydrolysis, oxidative, photolytic, and thermal degradation.

Results: The λ max of EMT, ten TDF, COB, and ELV are 283 nm, 259 nm, 240 nm, and 258 nm, respectively. The linearity ranges for the four drugs are EMT (4–24 μg/ml), TDF (10–50 μg/ml), COB (10–120 μg/ml), and ELV (2–10 μg/ml).

Conclusion: The Vierordt’s method was successfully applied for simultaneous determination of EMT, TDF, COB, and ELV in a mixture of sample solution (pharmaceutical dosage form) and the results obtained were validated and found to be accurate, precise, linear, rugged, and robust.


Keywords


Vierordt’s method, Emtricitabine, Tenofovir disoproxil fumarate, Cobicistat, Elvitegravir.

| PDF |

References


Sweetman SC, editor. Martindale - The Complete Drug Reference. 36th ed., Vol. 1. London, UK: Pharmaceutical Press; 2009.

Gilead Sciences “New Drug Applications for Cobicistat and Elvitegravir for HIV Therapy Accepted by U.S. FDA”, April 21; 2014.

Aids info Drug Database. Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate. Available from: https://www.aidsinfo.nih.gov/drugs/507/stribild/0/patient.

Highlights of Prescribing Information. STRIBILD® (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) Tablets, for oral use Initial U.S. Approval; 2012.

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.

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.

Elzanfaly ES, Saadn AS, Elaziz BA. A smart simple spectrophotometric method for simultaneous determination of binary mixtures. J Pharm Anal 2012;2:382-5.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Validation of Analytical Procedure. Text and Methodology. Edinburgh: Elsevier/Churchill Livingstone, European Medicines Agency; 1995. p. 229-44.

ICH Harmonized Tripartite Guideline. Validation of Analytical Procedures, Text and Methodology, Q2 (R1). Geneva, Switzerland: International Conference on Harmonization, IFPMA; 2005.

Pardhi SS, Aher KB, Bhavar GB, Chaudhari SR. Development and validation of UV spectrophotometric method for the estimation of elvitegravir (EVG) in bulk and pharmaceutical formulations. Int J Pharm Sci Res 2015;6:5.

Dhatkar D, Ahmad S, Shastry VM. Development and validation of UV-visible spectrophotometric method for estimation of emtricitabine and tenofovir in bulk and dosage form. Int J Pharm Pharm Res 2017;9:74-84.

Sri KV, Madhuri M, Jain GV. Multivariate UV-visible spectrophotometric method for the estimation of emtricitabine in bulk form. Int J Pharm Dev Technol 2015;5:89-93.

Gnanarajan G, Gupta AK, Juyal V, Kumar P, Yadav PK, Kailash P. A validated method for development of tenofovir as API and tablet dosage forms by UV spectroscopy. J Young Pharm 2009;1:351-3.

Kumar KA, Kannan K, Vetrichelvan T. Development and validation of emtricitabine and tenofovir disoproxil fumarate in pure and in fixed dose combination by UV spectrophotometry. Digest J Nanomater Biostruct 2011;6:1085-90.

Ravichandran V, Shalini S, Sundram KM, Rajak H. Validation of analytical methods – Strategies and importance. Int J Pharm Pharm Sci 2010;2:18-22.




About this article

Title

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING SIMULTANEOUS UVSPECTROPHOTOMETRIC METHOD FOR DETERMINATION OF EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE, COBICISTAT, AND ELVITEGRAVIR IN PURE AND PHARMACEUTICAL DOSAGE FORM

Topics

PHARMACY

Keywords

Vierordt’s method, Emtricitabine, Tenofovir disoproxil fumarate, Cobicistat, Elvitegravir.

DOI

10.22159/ajpcr.2018.v11i4.22897

Date

01-04-2018

Additional Links

Manuscript Submission

Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 11 Issue 4 April 2018 Page: 177-184

Print ISSN

0974-2441

Online ISSN

2455-3891

Statistics

30 Views | 65 Downloads

Authors & Affiliations

Harini U
Department of Pharmaceutical Analysis and Quality Assurance, University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.
India

Pawar Akm
Department of Pharmaceutical Analysis and Quality Assurance, University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India.
India


Article Tools


Email this article (Login required)
Email the author (Login required)

Refbacks

  • There are currently no refbacks.