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Research and Reviews: A Journal of Toxicology Original Research

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

  1. Nadapana Rakesh
  2. 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

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