Analytical Method Development and Validation of Etravirine by RP-UFLC

An ultra-fast liquid chromatography (RP-UFLC) approach was processed for the estimation of ETR, which is quick, responsive, reliable, and inexpensive. Work on the Phenomenex Kinetex C18 column (250x 4,6mm. 5μ) was carried out with MeOH and acetonitrile in the mobile phase ratio of (60:40v/v) at 1.0m...

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Veröffentlicht in:Research journal of pharmacy and technology 2021-07, Vol.14 (7), p.3537-3542
Hauptverfasser: M, Barath, R. S, Chandan, R, Maruthi, N, Paramakrishnan
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container_title Research journal of pharmacy and technology
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creator M, Barath
R. S, Chandan
R, Maruthi
N, Paramakrishnan
description An ultra-fast liquid chromatography (RP-UFLC) approach was processed for the estimation of ETR, which is quick, responsive, reliable, and inexpensive. Work on the Phenomenex Kinetex C18 column (250x 4,6mm. 5μ) was carried out with MeOH and acetonitrile in the mobile phase ratio of (60:40v/v) at 1.0mL/min. With a PDA detection system, the eluent was tracked at 311nm. ETR elutes at a persistence time of 3.226 min. The proposed method gives linearity of concentration from 1 to 5μg/mL, with the value of R2 at 0.9942%. For the proposed method, LOD and LOQ are measured as 0.02 and 0.073μg/mL. The pharmaceutical drug included acidic, alkaline, corrosion, Ultraviolet, and heat stress stipulations. The deterioration material was nicely resolved from ETR peaks, which showed the reliability of the process. The approach has been tested with respect to process adequacy, linearity, reliability, and robustness, as per ICH guidelines.
doi_str_mv 10.52711/0974-360X.2021.00613
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subjects Accuracy
Analytical chemistry
Antiretroviral drugs
Caustic soda
Chromatography
Efficiency
Enzymes
FDA approval
HIV
Human immunodeficiency virus
Hydrochloric acid
Mutation
title Analytical Method Development and Validation of Etravirine by RP-UFLC
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