Development and validation of LC/MS method for the determination of meclizine enantiomers in pharmaceutical formulations

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 (r²) 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.

Keywords:

• Meclizine
• hydrochloride
• enantiomers
• chirality
• LC-MS
• ICH
• validation
• chiral

Acknowledgements

The authors are grateful to His Holiness Jagadguru Sri Sri Shivarathri Deshikendra Mahaswamigalavaru of Sri Suttur mutt, Mysore for his blessings and the facilities provided to complete the research work successfully.

Disclosure statement

The authors declare no conflict of interest.

Data availability statement

All the data available at department of pharmaceutical analysis, JSS College of Pharmacy, Ooty.

Additional information

Funding

This work not supported by any funding agencies.