A simple, precise, accurate, efficient and reproducible, isocratic Reverse Phase- High
Performance Liquid Chromatography (RP-HPLC) method was developed and validated for the
simultaneous estimation of Emtricitabine, Tenofovir disoproxil fumarate and Rilpivirinehydrochloride in bulk and tablet dosage form. Emtricitabine, Tenofovir disoproxil fumarate and
Rilpivirine-hydrochloride were separated using an Phenomenex Luna 3? C8(2) 100A?
, LC
Column 150cm x 45mmand the mobile phase contained a mixture of 10mM Ammonium acetate
(pH adjusted to 5.7 with 0.1% triethylamine), Acetonitrile and Methanol (30:55:15v/v/v). The
flow rate was set to 0.8ml/min with the response measured at 250nm. The retention time of
Emtricitabine, Tenofovir disoproxil fumarate and Rilpivirine-hydrochloride was found to be
2.079min, 2.726min, 3.982min respectively with a resolution of 3.283, 5.675. Linearity was
established for Emtricitabine, Tenofovir disoproxil fumarate and Rilpivirine-hydrochloride in the
range of 10-50µg/ml for Emtricitabine, 20-100µg/ml for Tenofovir disoproxil fumarate, 5-
40µg/ml for Rilpivirine-hydrochloride with correlation coefficient of 0.9998, 0.9993 and 0.9994.
The percentage recovery of Emtricitabine, Tenofovir disoproxil fumarate and Rilpivirine-hydrochloride was found to be 99.98%, 100.03%, 100.05% respectively. Validation parameters
such as specificity, linearity, precision, accuracy, robustness, limit of detection (LOD), limit of
quantification (LOQ) was evaluated for the method according to the International Conference on
Harmonization (ICH) Q2 R1 guidelines.
Keywords: Emtricitabine, Tenofovir disoproxil fumarate and Rilpivirine-hydrochloride
RP-HPLC, ICH
Publication date: 01/01/2022
https://ijbpas.com/pdf/2022/January/MS_IJBPAS_2022_5837.pdf
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https://doi.org/10.31032/IJBPAS/2022/11.1.5837
