Development and Validation of Reverse-Phase High-Performance Liquid Chromatography Based Bioanalytical Method for Estimation of Simvastatin in Rat's Plasma
- 1 December 2022
- journal article
- research article
- Published by Mary Ann Liebert Inc in ASSAY and Drug Development Technologies
- Vol. 20 (8), 349-358
- https://doi.org/10.1089/adt.2022.080
Abstract
Simvastatin (SIM) is known to lower cholesterol levels and is speculated in the pathogenesis of Alzheimer's disease. In this study, the bioanalytical method of SIM SNEDDS was developed and validated for the estimation of SIM in the rat's plasma using reverse-phase high-performance liquid chromatography. C-18 reverse-phase octadecylsilyl column was used to validate the method. Atorvastatin (ATV) was used as an internal standard. Gradient elution was performed using acetonitrile and water in a ratio of 90:10 with a flow rate of 1 mL/min. The chromatogram of these both compounds SIM and ATV was detected at a wavelength of 238 and 244 nm. The drugs were extracted from the plasma samples using the protein precipitation method. The retention time of SIM and ATV was found to be 3.720 and 8.331 min, respectively. The developed method was found to be linear in the range between 50 and 250 ng/mL, with a regression coefficient (r2) of 0.9994. According to ICH M10 guidelines, the method was validated. The percent of drug recovery was more than 95% and the % relative standard deviation was <2% in the replicate studies, which showed that the method was accurate and precise. The limit of detection and limit of quantification were found in rat plasma to be 0.12 and 0.38 ng/mL, respectively. The obtained result indicated that the developed method was successful in estimating SIM in rat plasma and passed all validation test parameters.Keywords
This publication has 22 references indexed in Scilit:
- Simvastatin, dosage and delivery system for supporting bone regeneration, an update reviewJournal of Oral and Maxillofacial Surgery, Medicine, and Pathology, 2016
- Validated UPLC–MS/MS method for simultaneous determination of simvastatin, simvastatin hydroxy acid and berberine in rat plasma: Application to the drug–drug pharmacokinetic interaction study of simvastatin combined with berberine after oral administration in ratsJournal of Chromatography B, 2015
- International Conference on HarmonisationPublished by Elsevier BV ,2014
- Development of forced degradation and stability indicating studies of drugs—A reviewJournal of Pharmaceutical Analysis, 2013
- Use of Dried Plasma Spots in the Determination of Pharmacokinetics in Clinical Studies: Validation of a Quantitative Bioanalytical MethodAnalytical Chemistry, 2010
- Development and validation of a Sensitive bioanalytical method for the quantitative estimation of Pantoprazole in human plasma samples by LC–MS/MS: Application to bioequivalence studyJournal of Chromatography B, 2010
- Statin induced myopathyBMJ, 2008
- Genetic predisposition to statin myopathyCurrent Opinion in Rheumatology, 2008
- Statin myopathy as a metabolic muscle diseaseExpert Review of Cardiovascular Therapy, 2008
- Best practices during bioanalytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samplesThe AAPS Journal, 2007