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- Title
Development and Validation of Stability-Indicating UPLC Method for Simultaneous Determination of Glecaprevir and Pibrentasvir.
- Authors
Susmita, Adepu Geetha; Rajitha, Galla
- Abstract
A rapid and sensitive reverse phase ultra-performance liquid chromatography (RP-UPLC) method has been developed for the simultaneous estimation of glecaprevir (Glec) and pibrentasvir (Pib) in pharmaceutical formulations. The developed method was run through Acquity UPLC CHS C18 (50 × 2.1 mm, 1.7 m) column utilizing the mobile phase of OPA buffer (pH 4.2)—acetonitrile (60:40 v/v) at a flow rate of 0.35 mL/min and column temperature of 30°C. The eluents were detected with TUV detector at a wavelength of 260 nm. The retention times for Glec and Pib were 0.425 and 0.755 min, respectively. The calibration curves were linear with R2 values of 0.9996 and 0.9993 calculated from regression equations for glecaprevir (y = 5486.4x + 1700.1) and pibrentasvir (y = 5201.3x + 771.27), respectively. The calculated %RSD values of Glec and Pib were 0.3 and 0.8, and the percentage recoveries were 100.05 and 99.66%, respectively. In the forced degradation studies performed according to ICH guidelines, the drug samples were exposed to different stressed conditions and the results showed that all degradation products were satisfactorily separated from each other and from the peaks of drugs. The proposed method proved to be simple, fast, accurate, precise, reproducible and robust. Hence, it can be applied for routine quality control analysis of glecaprevir and pibrentasvir in bulk and pharmaceutical formulations.
- Subjects
REVERSE phase liquid chromatography; MICELLAR liquid chromatography; QUALITY control; RF values (Chromatography)
- Publication
Pharmaceutical Chemistry Journal, 2022, Vol 56, Issue 1, p138
- ISSN
0091-150X
- Publication type
Article
- DOI
10.1007/s11094-022-02611-4