A New Method Using the RP-HPLC Method Was Developed For the Simultaneous Estimation of Grazoprevir and Elbasvir

Author(s): Manjunath S.Y, Anusha Rapelli, Ravindar Bairam, P. Balakrishanaiah

Publication #: 2412079

Date of Publication: 20.01.2025

Country: India

Pages: 1-10

Published In: Volume 11 Issue 1 January-2025

Abstract

For the simultaneous measurement of Elbasvir and Grazoprevir in pharmaceutical dose form, a straightforward, accurate, and exact approach was created.

A chromatogram measuring 250 x 4.6 mm and 5µm was conducted through symmetry C18. At a flow rate of 1 milliliter per minute, a mobile phase of 0.1% orthophosphoric acid:acetonitrile (55:45, v/v) was pumped through the column. Ambient temperature was maintained. 260 nm was the ideal wavelength for Elbasvir and Grazoprevir.

Elbasvir and grazoprevir were shown to have retention times of 3.848 and 2.313 minutes, respectively. Elbasvir and grazoprevir were determined to have purity percentages of 100.4% and 100.2%, respectively. Elbasvir and Grazoprevir's system suitability characteristics, including theoretical plates and tailing factor, were determined to be 3568.30 and 4836.12, respectively. Elbasvir and Grazoprevir's linearity investigation revealed that their concentration ranges were 12.5 μg-75 μg and 25 μg-150 μg, respectively. Their correlation coefficients (r2) were 0.999 and 0.999, their percentage mean recovery was 100.19 % and 100.84 %, and their percentage RSD for repeatability was 0.75 and 0.36 %. The precision study was repeatable, reliable, and accurate. The LOQ values were 1.05 and 0.23, while the LOD values were 0.082 and 0.357, respectively.

The study's findings demonstrated the simplicity, accuracy, precision, robustness, speed, and reproducibility of the suggested RP-HPLC approach, which could be helpful for routinely estimating Elbasvir and Grazoprevir in pharmaceutical dosage forms.

Keywords: Elbasvir, Grazoprevir, RP‐HPLC, Simultaneous estimation

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