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ISSN 2063-5346
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HPTLC method development for bictegravir, emtricitabine and tenofovir in bulk and dosage form in presence of its degradation products

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Charushila J Bhangalea * and Shivanand N Hiremathb
» doi: 10.48047/ecb/2023.12.4.253

Abstract

Simple, accurate and stability-indicating high-performance thin- layer chromatographic method for densitometric determination of Bictegravir, Emtricitabine and Tenofovir in bulk and in dosage form was developed and validated as per the ICH guidelines . TLC aluminium plates precoated with silica gel 60F 254 - (Merck, Germany) as the stationary phase were used in the method development. Toluene: Ethyl acetate: methanol: acetic acid (4.0:3.0:3.0:0.2 v/v/v) was used as the development solvent. Bictegravir, Emtricitabine, and Tenofovir were densitometrically measured in absorbance mode at 272 nm. The system was found to give very well resolved spot for Bictegravir, Emtricitabine and Tenofovir at Rf value of 0.26, 0.42 and 0.63 respectively.The calibration curve of the drug 200 to 1600 ng/spot for BIC, 100-800 ng/spot for TAF and concentration range 500 to 4000 ng/spot for ETB was observed. The correlation of coefficient was found to be 0.998 for BIC, 0.9994 for ETB and 0.999 for TAF. The regression line equation for Bictegravir, Emtricitabine and Tenofovir was found to be y = 2.785 x + 2415, y = 1.789 x + 2743 and y = 1.644 x + 2843 respectively. The %RSD less than two indicates method is precise and accurate. In HPTLC

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