UPLC Method Development and Validation for Sofosbuvir, Velpatasvir, and Voxilaprevir Determination

It has been stated that an ideal analytical technique is highly desirable for formulating pharmaceutical prescription. This work describes and validates the new UPLC method for the identification of Sofosbuvir, Velpatasvir, and Voxilaprevir in drug products. Details of developed method was checked for precision, accuracy, linearity, sensitivity and robustness and found it abide ICH guidelines for validation. The chromatographic separation was done on a C18 column and a gradient mobile phase of acetonitrile and buffer at certain conditions. All the analytes were estimated at 260 nm. The selected method displayed a perfect linear response within high concentration levels of the drug more than 0.999 with the merits values for all three drugs. Validation results provided further support to the suitability of the described method in routine quality control analysis where this approach would stabilize pharmaceutical quality assurance in terms of rapidity and cost-effectiveness.

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Publication Details

Journal
Journal of Neonatal Surgery
Published
2025-02-07
DOI
https://doi.org/10.52783/jns.v14.1612
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
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article

UPLC Method Development and Validation for Sofosbuvir, Velpatasvir, and Voxilaprevir Determination

Samson Israel. D, Aroun Prasath, Kavitha Parthasarathy, M. L. Surekha et al.
Journal of Neonatal Surgery
Analytical Methods in Pharmaceuticals
article

UPLC Method Development and Validation for Sofosbuvir, Velpatasvir, and Voxilaprevir Determination

Samson Israel. D, Aroun Prasath, Kavitha Parthasarathy, M. L. Surekha, Dileep Kumar Garnipudi
article en

Abstract

It has been stated that an ideal analytical technique is highly desirable for formulating pharmaceutical prescription. This work describes and validates the new UPLC method for the identification of Sofosbuvir, Velpatasvir, and Voxilaprevir in drug products. Details of developed method was checked for precision, accuracy, linearity, sensitivity and robustness and found it abide ICH guidelines for validation. The chromatographic separation was done on a C18 column and a gradient mobile phase of acetonitrile and buffer at certain conditions. All the analytes were estimated at 260 nm. The selected method displayed a perfect linear response within high concentration levels of the drug more than 0.999 with the merits values for all three drugs. Validation results provided further support to the suitability of the described method in routine quality control analysis where this approach would stabilize pharmaceutical quality assurance in terms of rapidity and cost-effectiveness.

Journal of Neonatal SurgeryVol. 14(1S)
Openalex Percentile: Top 96%
Analytical Methods in Pharmaceuticals
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