Development and validation of a new RP-HPLC Method for the simultaneous estimation of Lamivudine, Doravirine and Tenofovir disoproxil fumarate in combined dosage form

Registration ID: IJNRD_226834

Published ID: IJNRDTH00187

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Aneesha Kappen , Satya V

Key Words: Lamivudine, Doravirine, Tenofovir disoproxil fumarate, RP-HPLC, method development, validation.

A new, simple, accurate and specific RP-HPLC method was developed for the simultaneous estimation of the Lamivudine, Doravirine and Tenofovir disoproxil fumarate in combined solid dosage form. The chromatogram was run through Kromasil C18 250x4.6mm, 5 column. Mobile phase containing a buffer and acetonitrile in the ratio of 60:40 v/v was pumped through the column at a flow rate of 1ml/min. Buffer used in this method was 0.1% OPA. Temperature of system was maintained at 30°C. The optimized wavelength for Lamivudine, Doravirine and Tenofovir disoproxil fumarate was 272.0 nm. Retention time of Lamivudine, Doravirine and Tenofovir disoproxil fumarate were found to be 2.314 min, 4.616 min and 3.196 min. % RSD of system precision for Lamivudine, Doravirine and Tenofovir disoproxil fumarate were found to be 1.0, 0.9 and 1.0 respectively. % RSD of method precision for Lamivudine, Doravirine Tenofovir were found to be 0.5, 0.7 and 0.5 respectively. % Recovery was obtained as 99.57%, 99.89% and 99.74% for Lamivudine, Doravirine and Tenofovir disoproxil fumarate respectively. LOD values obtained from regression equations of Lamivudine, Doravirine and Tenofovir disoproxil fumarate were 0.27 ppm, 0.09 ppm and 0.18 ppm, and LOQ values obtained from regression equations of Lamivudine, Doravirine and Tenofovir disoproxil fumarate were 0.82ppm, 0.28 ppm and 0.54ppm respectively. Regression equation of Lamivudine was y = 14959x + 1184, Doravirine was y = 28129x + 2766 and of Tenofovir was y = 17361x + 6030.

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Aneesha Kappen & Satya V (August-2024). Development and validation of a new RP-HPLC Method for the simultaneous estimation of Lamivudine, Doravirine and Tenofovir disoproxil fumarate in combined dosage form . INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 9(8), 243-312. https://ijnrd.org/papers/IJNRDTH00187.pdf

Volume 9 Issue 8, August-2024

Pages : 243-312

Paper Reg. ID: IJNRD_226834

Published Paper Id: IJNRDTH00187

Research Area: Pharmacy

Author Type: Indian Author

Country: Kasaragod DT, Kerala , India

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