Nadapana Rakesh
D.Swapna
Abstract
Hence, proposed analytical methods are simple, novel, economical, rapid,
sensitive, reproducible and accurate for the Simultaneous estimation of Tenofovir Disoproxil
Fumarate, Emtricitabine and Isoniazid in Bulk and Phamaceutical dosage form by using RP-
HPLC. This Method gives reliable assay results with short analysis time using mobile phase
of Acetonitrile : 0.02M Potassium Dihydrogen Orthophosphate: water (pH 5.3) in the ratio of
60: 25: 15 respectively. Retention time was found to be 2.3 min, 3.7min and 4.9 min for
Tenofovir Disoproxil Fumarate, Emtricitabine and Isoniazid respectively. System suitability
parameters were in the desired Limit. This method has been developed and optimized as per
ICH Q2 (R1) guidelines. With Sunfire C18 column,the drugs gets eluted with good peak and
the pressure was within the limit. Validation parameters, Linearity was found to be 10-
50μg/ml for Emtricitabine and 15-75 μg/ml for both Tenofovir Disoproxil Fumarate and
Isoniazid. Correlation coefficient was found to be 0.999, 0.999 and 0.999 for Tenofovir
Disoproxil Fumarate, Emtricitabine and Isoniazid respectively. Accuracy was found to be
100.3%, 100.1% and 100.3% for Tenofovir Disoproxil Fumarate, Emtricitabine and Isoniazid
respectively. Precision was found to be 0.7, 0.6 and 0.7 for Tenofovir Disoproxil Fumarate,
Emtricitabine and Isoniazid respectively. LOD and LOQ was found to be 1.08, 3.2 for
Emtricitabine, 1.69, 5.1 for Tenofovir Disoproxil Fumarate and 1.10, 3.3 for Isoniazid.
Specificity (Blank interference), no peaks was observed at the retention time of Tenofovir
Disoproxil Fumarate, Emtricitabine and Isoniazid in the Chromatogram of blank. System
suitability, Tailing factor was 1.38, 1.42 and 1.51, Theoretical plates was 2079, 3388 and
4093 of Tenofovir Disoproxil Fumarate, Emtricitabine and Isoniazid respectively. Resolution
was found to be within 2mins for both three drugs. % RSD for all the validation parameters
were within the limit(NMT 2.0)
Keywords: Tenofovir Disoproxil Fumarate, Emtricitabine, Isoniazid, Pharmaceutical dosage form, RP-HPLC
References
1. FDA Approved Drug Products: Emtriva (Emtricitabine) Oral Capsules
2. FDA Press Announcements: FDA approves second drug to prevent HIV infection as
part of ongoing efforts to end the HIV epidemic.
3. Storch CH, Theile D, Lindenmaier H, Haefeli WE, Weiss J: Comparison of the
inhibitory activity of anti-HIV drugs on P-glycoprotein. Biochem Pharmacol. 2007
May 15;73(10):1573-81.
4. Soriano V, Labarga P, Fernandez-Montero JV, Mendoza C, Benitez-Gutierrez L, Pena
JM, Barreiro P: Drug interactions in HIV-infected patients treated for hepatitis C.
Expert Opin Drug Metab Toxicol. 2017 Aug;13(8):807-816.
5. Pym AS, Domenech P, Honore N, Song J, Deretic V, Cole ST: Regulation of
catalase-peroxidase (KatG) expression, isoniazid sensitivity and virulence by furA of
Mycobacterium tuberculosis. Mol Microbiol. 2001 May;40(4):879-89. [Article]
6. Heym B, Alzari PM, Honore N, Cole ST: Missense mutations in the catalase-
peroxidase gene, katG, are associated with isoniazid resistance in Mycobacterium
tuberculosis. Mol Microbiol. 1995 Jan;15(2):235-45. [Article]
7. Wilson TM, de Lisle GW, Collins DM: Effect of inhA and katG on isoniazid
resistance and virulence of Mycobacterium bovis. Mol Microbiol. 1995
Mar;15(6):1009-15. [Article]
8. Vilcheze C, Jacobs WR Jr: The mechanism of isoniazid killing: clarity through the
scope of genetics. Annu Rev Microbiol. 2007;61:35-50. [Article]
9. MD Abdul Sattar* and Suneetha Achanta. Analytical Method Development and
Validation for the Determination of Emtricitabine and Tenofovir Disoproxil Fumarate
Using Reverse Phase HPLC Method in Bulk and Tablet Dosage Form. /J. Pharm. Sci.
& Res. Vol. 10(5), 2018, 1207-1212
10. Shah A.U., Kotadiya V. V., Ajmera A. A. Department of Quality Assurance, K.B.
Raval College Pharmacy, Gandhinagar-382423, India. Research J. Pharm. and Tech.
2016; 9(4): 463-468.
11. Ramaswamy, Anton Smith Arul Gnana Dhas, Development and validation of
analytical method for quantitation of Emtricitabine, Tenofovir, Efavirenz based on
HPLC, Arabian Journal of Chemistry,2018,11(2),275-281
12. Tej Kumar Kokkirala & Duvvuri Suryakala (2019) 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, 13:1, 1137-1146.
13. Rao BV, Vidyadhara S, Nagaraju B and Jhonbi SK: A novel stability indicating RP-
HPLC method development and validation for the determination of tenofovir
disoproxil fumarate and emtricitabine in bulk and pharmaceutical formulations. Int J
Pharm Sci Res 2017; 8(5): 2168-76
14. Reddy BRY, Reddy MT, Reddy BSC (2015) Simultaneous Estimation of
Emtricitabine and Tenofovir Disoproxil Fumarate in Tablet Dosage Form by Reverse
Phase High-performance Liquid Chromatography. SOJ Chromatograph Sci 1(1): 6.
15. Sharma R, Gupta P. A Validated RP – HPLC Method for Simulataneous Estimation of
Emtricitabine and Tenofovir Disoproxil Fumarate in a Tablet Dosage Form. Eurasian
Journal of Analytical Chemistry. 2009;4(3):276-284.
Research & Reviews: A Journal of Toxicology
| Volume | |
| Received | February 8, 2024 |
| Accepted | February 10, 2024 |
| Published | March 30, 2024 |