Development and validation of a method for simulataneous determination of tenovifir disoproxil fumarate emtriculabine and isonized in bulk and pharmaceutical dosage form using RP-HPLC with relevance to toxicological aspects

Year : 2024 | Volume :14 | Issue : 01 | Page : 17-25
By

Nadapana Rakesh

Dr.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

[This article belongs to Research & Reviews: A Journal of Toxicology(rrjot)]

How to cite this article: Nadapana Rakesh, Dr.D.Swapna. Development and validation of a method for simulataneous determination of tenovifir disoproxil fumarate emtriculabine and isonized in bulk and pharmaceutical dosage form using RP-HPLC with relevance to toxicological aspects. Research & Reviews: A Journal of Toxicology. 2024; 14(01):17-25.
How to cite this URL: Nadapana Rakesh, Dr.D.Swapna. Development and validation of a method for simulataneous determination of tenovifir disoproxil fumarate emtriculabine and isonized in bulk and pharmaceutical dosage form using RP-HPLC with relevance to toxicological aspects. Research & Reviews: A Journal of Toxicology. 2024; 14(01):17-25. Available from: https://journals.stmjournals.com/rrjot/article=2024/view=134786


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Regular Issue Subscription Original Research
Volume 14
Issue 01
Received February 8, 2024
Accepted February 10, 2024
Published March 13, 2024