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Development and validation of LC/MS method for the determination of meclizine enantiomers in pharmaceutical formulations.
- Source :
-
Drug development and industrial pharmacy [Drug Dev Ind Pharm] 2021 Mar; Vol. 47 (3), pp. 361-366. Date of Electronic Publication: 2021 Feb 19. - Publication Year :
- 2021
-
Abstract
- An enantiomeric separation of meclizine enantiomers by liquid chromatography with tandem mass spectrometry LC-MS method was developed and validated for the analysis of Meclizine enantiomers. Enantiomeric resolution of the drug products were successfully achieved on a Phenomenex® lux cellulose 1 C18 (250 mm × 4.6 mm i.d, 5 µm particle size) column with mobile phase consisting of acetonitrile: 5 mM ammonium format pH (5.5) adjusted with formic acid (90:10) (v/v), and a flow rate of 0.4 mL/min. The developed method provided linear responses within the concentration range 1-5 ng/mL, and regression analysis showed a correlation coefficient value (r <superscript>2</superscript> ) of 0.999. The optimized mobile phase separated (+) Meclizine at 1.58 min and (-) Meclizine at 2.20 min, respectively. The LC/MS method was validated as per ICH guidelines with respect to specificity, precision, linearity and robustness. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 1.0 ng/mL and 5.0 ng/mL respectively. The proposed method is suitable for analysis of meclizine enantiomers in pharmaceutical formulations and quality control analysis.
Details
- Language :
- English
- ISSN :
- 1520-5762
- Volume :
- 47
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Drug development and industrial pharmacy
- Publication Type :
- Academic Journal
- Accession number :
- 33291999
- Full Text :
- https://doi.org/10.1080/03639045.2020.1862174